YES NO
1 Do you continually crave sugary foods or drinks?
2 Are you plagued by an uncontrollable, intense thirst?
3 Are you finding it difficult to sleep through the night?
4 Do you find it virtually impossible to lose weight?
5 Is your judgement of distance somewhat impaired?
6 Do you find it difficult to think clearly at all times?
7 Do you crave food between meals and raid the fridge at night?
8 Do you continually forget to remember important things?
9 Is your eyesight forever changing its focus?
10 Does climbing a flight of stairs sometimes exhaust you?
11 Do you have mood swings that surprise even you?

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

12 Do you often feel lethargic and depressed?
13 Could you be described as ‘barrel-shaped’ (by your enemies)?
14 Does a frequent urge to urinate hinder your mobility?

The number of people with sugar-related problems is climbing rapidly, but more worrying is that few sufferers know of their condition or understand the triggers. For this reason, and due to the expense, they don’t follow up what they consider minor, stress-related complaints. If you answered ‘yes’ to any of the questions above, you could be pre-diabetic or diabetic and early diagnosis could make an incredible difference to your ‘quality of life’.

As we age, our metabolism often works less efficiently. Losing weight becomes increasingly difficult and the array of super-processed foods at local supermarkets, make dieting difficult. We have allowed food manufacturers too much control over our intake, trusting their highly paid dieticians and food technologists to know what is good for us. Since their ultimate goal is to sell more products,

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

heir intentions differ radically from ours.

Check the ingredient labels on the pre-prepared supermarket goods in your grocery cupboards and ’fridge; would you expect to find sugar and modified cornstarch in everything from carrot salad to tinned meats? They are there, do us no good and can even be harmful.

Scientists used to believe that heart conditions could be blamed on our genes: if a parent had died of heart-related symptoms, the child was likely to suffer the same consequences. But our long-term eating habits can be as much to blame as any fault of birth. Each generation appears to increase the risks with simple, but deadly, lifestyle choices and bad habits: what we eat and exercising less.

Everything we eat, turns to sugar in our bodies. This sugar fuels our energy. If our bodies are starved of it, they will die. If they are regularly over-loaded with sugar, in conjunction with high cholesterol or high blood pressure, heart disease can result. Untreated sugar overload can also have several other nasty consequences. Insulin, manufactured by the pancreas, in

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ects blood sugar into the cells. Whenever we eat, insulin-production in the pancreas should increase, in order to enable our cells to metabolise the sugar from the food and then use it, in the form of energy.

When this doesn’t happen, our bodies cannot process the sugar they need. Excess sugar then turns into fat, which is largely stored around the midriff. So: a side effect of the inability of the body to process fuel properly, is excess weight, which becomes an additional burden to a fragile heart/pulmonary system.

Nearly half of all who suffer from heart attacks, also share another common, purely diet-related metabolic problem: pre-diabetes. This ‘insulin-resistance syndrome’ has now been conclusively linked to obesity and heart health.

Action plan 1:

1. If you answered ‘yes’ to some of the initial questions, have a simple finger-prick test at a pharmacy.

2. See a doctor, if so advised. He/she will follow up with a diet plan, oral or insulin medication, if necessary.

3. If your answers were all negative and you are very active, remain aware that diabetes

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

is now manifesting in younger people; eat and exercise wisely to remain fit. Help yourself and your family by cutting down on all drinks containing sugar – fizzy drinks, cordials and fruit juice. Eat fewer sweets.

There are two main types of diabetes: Type 1 and Type 2. Type 1 is considered the more serious and has historically been diagnosed in young children. Type 2 was previously commonly called ‘adult onset’ diabetes and generally appeared around middle age, but is now seen far more often in much younger adults and even in children.

A third type does actually exist, but has only recently become frequently mentioned. ‘Pre-diabetes’ describes the stage where body cells begin to resist metabolising sugar intake. People with this condition are not actually diabetic yet, but soon will be, unless steps are taken to reverse the situation. This condition also indicates a clear link to future heart disease.

Diabetes, its stages and types

Normal Indications – Insulin is produced and blood sugar is absorbed by cells for energy.


Symptoms – Feeling fantasti

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

.


Possible consequences – Dying of old age.


Management – Eat healthily, exercise regularly and be aware.
Pre-diabetes Indications – Fluctuating blood-sugar levels; often misinterpreted general malaise.


Symptoms – See quiz in previous issue.


Possible consequences – Type 1/2 diabetes.


Management – Sensible and regular eating, more exercise.
Type 1 diabetes Indications – Insufficient insulin production and low carbohydrate metabolism.


Symptoms – Very high sugar levels/coma.


Possible consequences – Heart disease, kidney failure amputations, blindness, etc.


Management – Diet, insulin injections and daily exercise.
Type 2 diabetes Indications – Insulin production usually normal but cells resist sugar absorption.

Symptoms – High sugar levels.


Possible consequences – Heart disease, kidney failure amputations, blindness, etc.


Management – Diet, daily exercise + possible medication.

Doctors and dietitians work with diabetics to find the correct medication dosages and diets to control their levels of su

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ar resistance. To most diabetics, the most difficult part of the illness is the diet. As with heart-healthy diets, boredom is the danger of limiting food-intake, long-term.

Diabetics want acceptable, affordable, healthy treats to take the place of forbidden foods and can be frustrated by price and availability. The main aim is to keep blood sugar at a reasonably low level at all times, with cells neither over- nor under-loaded. This indicates a need for more regular, but smaller, meals; which keep the metabolism constantly active, but discourage sugar ‘spikes’ (sudden raised sugar levels). Well-behaved diabetics eat something every two hours, but have smaller meals and regular snacks in between.

What constitutes a ‘snack’ is of vast importance – if it’s pre-packaged in foil, it’s bound to be bad! Added vitamins, iron, etc. in processed foods are only necessary when all the original vitamins and iron have been purged by the refining process – avoid them. Better, by far, are small pieces of deciduous or citrus fruit, a dozen or so unsalted nuts or lean protein with

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

raw salad vegetable.

It seems that previous generations were getting right what we, with all our superior scientific, manufacturing and technological knowledge, have not. A book on nutrition, published in 1950, tells me that the only foods likely to sustain us from breakfast until lunchtime are eggs and milk. The Scots, of course, swear by oats porridge and for many South Africans, mielie meal is the obvious choice.

What many diabetics have only found out recently, is that all refined (white) starch is virtually as unhealthy as spooning sugar down your throat. Yellow mielie meal and slow-cooked oats are far better choices than instant or ‘quick cooking’ alternatives. In the novel, The Power of One, Courtney Bryce maintains that the Apartheid government came into power on the strength of a single, simple promise: making white bread available again in post-war SA. How easily is Man swayed and an entire nation’s health destroyed!

Measuring sugar levels

Measuring blood sugar levels is about taking readings before and after we eat and remembering that everything we

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

at or drink converts to sugar. It doesn’t have to look like sugar to act like it! The latest friend to diabetics is the GI (Glycaemic Index) and its introduction has disproved many of the theories that nutritionists previously recommended. The GI measures the rate at which particular foods raise sugar levels in the blood and thus points to some foods that should be avoided and others that have little reaction on our blood sugar levels. The best news of all, perhaps, is that it recommends yet others that actually reduce sugar levels naturally.

Action plan 2 1 Ask your local supermarket whether they have any GI pamphlets. These list the GI indices of

various starches, fats, fruits, vegetables and proteins, enabling wiser shopping choices.
2 To improve your family’s general health and reduce future risk of diabetes and heart disease, try

reading The South Beach Diet by Dr Arthur Agatston (published by Headline) or The Sugar

Solution by Sar? Harrar & associates (published by Prevention Health Books).
2 Do something active with your kids every da

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

, even if it’s only walking around the garden or

throwing and catching a ball.
3 Cut down on all white, refined carbohydrates – bread, rice, pasta, mielie meal and potatoes.

Switch to seed bread, brown rice/pasta and yellow meal, to feel fuller, for longer and easy to eat

slightly smaller portions.

The sugar/heart link

Cardiologists once taught that eating fat clogged our arteries, causing blockages in our blood vessels. These blockages starved our organs of oxygenated blood and caused strokes and heart attacks. Patients eliminated all fat and fat-containing foods from their diet. TV advertising continually reminds us that certain margarines are considered ‘heart-safe’, while all animal fats are taboo. At another level, debates revolve around hydrolysed, good and bad fats.

Essentially, the biggest problem encountered with heart patients was that the low-fat, high carbohydrate diet advised by Heart Associations was unsustainable. Once patients became bored and disillusioned, they risked dying younger over living miserably. Moreover, those who managed to

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

stick to the diet, saw little improvement in their blood chemistry.

Opinions have changed quite radically over the last ten years: while heart patients still monitor what they eat, those fats we usually call ‘oils’ are now considered necessary for lowering cholesterol. These include olive and rapeseed oil, fish oils, avocado pears, nuts and seeds. Other food, previously banned, is now considered good for us in reasonable quantities: dairy products, eggs, lean red meat and prawns, for example.

For those who once existed on a diet of skinless chicken breasts, white fish, salads and un-spread bread, this is a relief. Cholesterol is something our bodies cannot do without but abnormal amounts in the blood make us targets for heart disease.

Weighty problems

Certainly, many heart patients are overweight; just as some, but not all, have high cholesterol or high blood pressure (these do not always go hand-in-hand). Defining the profile has been difficult, but cardiologists are slowing coming to agreement: the most common denominator in heart patients, is diabetes or pre-

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

iabetes.

Continual high blood-sugar levels are now considered responsible for changing the chemistry of our blood, making it stickier and thus causing clots to lodge along our blood vessels. And high blood sugar is caused mostly by two simple factors: the way and what we eat, and a lack of exercise. High blood sugar damages eye capillaries, resulting in diabetic retinopathy, a leading cause of blindness. It also raises the likelihood of glaucoma and cataracts.

Just because diabetes is manageable, does not mean it is not serious. Continual overindulgence will lead to a reduction of options. Once diabetes options are depleted, people lose limbs, go blind, have kidneys damaged beyond repair, etc.

Prehistoric man’s part

Cave men, women and children seldom enjoyed three meals a day. When Mr C. Man occasionally managed to make a kill, they all gorged on a hearty meal – with no ’fridges to keep the kill fresh, dangerous animals were likely to scrounge anything set aside for the following day. Our bodies were designed to convert excess intake into fat, so that a few wee

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

s of sparse eating would not herald our demise. Unfortunately, biological evolution has been slower than technological revolution and our brains have not yet adapted to our more regular eating patterns.

Genetic programming often supersedes mindset. Now that most of us eat far more regularly, we store fat that is never burnt off and even if we eat less than a regular three meals a day, our bodies become confused and store whatever they can, believing that our restraint may herald the onset of famine.

However, even if we don’t eat three meals a day, we often eat at one meal, as much as we should at three (still thinking like cave men). When this happens, our bodies store more fat than normal, especially around the core, mid-section of our bodies. Because we don’t do as much exercise as our friend, Mr C. Man, we are, quite literally, stuck with it.

Counting down

There has been a huge focus on exercise needs for over 30 years, but how many of us really listen? We have also been pumped full of theories relating to heart rate, aerobic versus anaerobic and other varied

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

masochistic extremes. The upwardly mobile indulge themselves at gyms, at immense cost, to follow exercise trends and to find mates. What about ordinary people, though?

The latest theories should be music to our ears – exercise for twenty minutes every day (any more is not considered absolutely necessary for general good health). Walking is sufficient and there is, we are now told, no need to force the heart rate up too high. Walking reduces stress levels and cheers you up, because it releases mood-enhancing endorphins in your brain. Other theories suggest that walking 15 000 steps each day, will keep you fit. This will take between 2 and 4 hours; if your job entails lots of footwork, that’s fine.

Reducing overall health risk is really all about retraining the next generation. Don’t exclude your kids from an exercise program; keep it simple and avoid expensive gym memberships: equipment work is too strenuous for under-age children. Pre-school children are now being diagnosed with Type 2 diabetes and the researchers are blaming it all on TV.

Action plan 3
1

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

Deal with the excuses: time and cost.
2 Is spending 20 minutes with your kids, every day, too much to ask?
3 Wrestle on the carpet, kick a ball, walk part of the way to school together; move the action to a

public pool in summer or into the school playground during the winter. Start a community

gardening project or get a group together to maintain the school grounds?
4 Talk while you walk and laugh while you swim.
5 Whenever possible, keep discreetly active.
6 Cut down your alcohol intake – even beer causes a sugar spike. Best tactic? A single drink,

preferable a glass of red wine, drunk with a meal (not before it) so that your food can reduce the resulting rise in your blood sugar levels.

The Glycaemic Index can initially seem very complicated. We have all been told repeatedly that a healthy diet includes lots of fruit and vegetables, but this is not necessarily so; eating the correct fruit and vegetables is as important. These tips will make choices, easier to make…

1 Never skip meals; rather eat six small meals a day.

Su

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ar takes between 1.5 and 2 hours to reach your blood stream, after eating. To keep blood sugar levels constant, we need to eat between breakfast, lunch and supper and again, before we go to bed. Miss a meal or snack, sugar levels will drop and you’ll overeat at the following meal.

A matchbox-sized piece of cheese with celery, a small handful of unsalted nuts or an apple make ideal between-meal snacks, If you have a sweet tooth, try sugar-free yoghurt during the evening. Controlling food intake is easier if you eat more, but smaller, meals every day.

2 …the harder the metabolism must work to extract the sugar from food, the better.

For many years, carbohydrates were advised as the best basis of a diabetic diet, with protein kept to a minimum. A GI-related diet recommends lean protein as the best source of ongoing energy. Eat at least one low GI food with every meal and always include a low-GI vegetable. An omelette or scrambled egg for breakfast, with mushrooms or tomato, takes little more time to make than a slice of toast. And yes, an egg every day IS good f

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

r you and cheap!

3 Low-GI vegetables

Normal salad vegetables, green, leafy vegetables and marrows, cauliflower and broccoli are all ‘okay’. The older the vegetable is, the higher its sugar content. Garlic, ginger, onions and lemon juice have nutritional merit. Beans and lentils, in soups and stews appear to lower sugar levels.

4 High-GI vegetables

Don’t avoid yellow and orange vegetables and root vegetables, but eat these in only small quantities – pumpkin, butternut, carrots, beetroot, turnips and potatoes are all fairly high in sugar. Reduce the size of helpings; never add sugar during cooking and avoid frying in fat or sunflower oil.

5 Low- and high-GI fruit

Deciduous fruit, citrus fruit and all berries are considered best; tropical fruit, paw-paw excepted, generally has a very high sugar content. Be wary of bananas and watermelon. Cinnamon is said to increase the effectiveness of your body’s insulin and stimulate the production of glucose burning enzymes, so try it sprinkled over fruit.

6 Don’t avoid good protein

The calcium in dairy product

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

helps you to lose weight and keeps your blood sugar in balance. Look for low fat, low sugar options, but a glass of milk or a slice of hard cheese is far healthier than pre-packed chips, snacks, sweets, biscuits or chocolate (and cheaper). The fat in dairy products satisfies the appetite. Cottage cheese and eggs are less expensive than meat.

7 Oils and fats

Fats are satisfying and therefore help us to know when we have eaten enough. Cut out fatty meat and cut down on red meat, but heart-advised margarine, olive, peanut and rapeseed oils are considered fine. Small quantities of unsalted nuts (almonds are considered the best) or sugar-free peanut butter can be eaten daily. Avocado pear is a delicious substitute for meat. Avoid sausages and boerewors – too fatty – but enjoy the occasional, trimmed steak.

8 Carbohydrates

Excess weight comes largely from carbohydrates, especially the highly processed ones. Modern, industrial processing removes the fibre from food, which, in turn, significantly changes the metabolic process. The Glycaemic Index clarifies the ab

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

olute relationship between carbohydrates and sugar. If you decrease bad carbohydrates, insulin-resistance retreats, weight decreases, metabolism improves, carbohydrate cravings disappear and blood chemistry improves.

Change from corn flakes and refined cereals, to sugar-free muesli; from white or whole wheat bread, to seed bread; from white to brown rice, pasta, flour, etc. Surprisingly, sweet potatoes are lower GI than plain potatoes. Most important is to reduce portions slightly. Eat no more starch than could fit into a tennis ball, but also, don’t omit carbohydrates completely for any longer than two weeks.

9 Sweet tooth?

Ideally, diabetics should avoid sugar completely, but who’s perfect? Men are less inclined to admit to cravings, while women often view chocolate as a cheaper version of Prozac. Bearing in mind that refined starches raise blood sugar levels as quickly as sugar, never be fooled by the notion that sugar only exists in cakes and sweets.

Fast, pre-packaged, processed and tinned foods, flavourings, sauces, crisps, pickles, dressings, etc. ofte

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

contain liberal sugar- and refined-starch additives. Avoid them and start using spices and herbs for flavouring. Note which of your favourite foods contain sugar and reduce the size and frequency of your portions, eating more low-GI vegetables to compensate.

And if you must eat cake or sweets, train yourself to eat those that do the least harm: a small portion of ice cream, egg custard, a bran muffin, milk tart, cheesecake or a whole wheat biscuit, instead of icing-covered confections made with lots of white flour. Boiled sweets are sugar-rich whereas a small portion nut chocolate (preferably dark) is occasionally excusable. Chocolate and red wine contain protective anti-oxidants, but should be consumed sparingly.

10 Lifestyle change

Don’t go hungry – continuously level, low, blood sugar stops hunger cravings and you will begin to enjoy natural tastes again. You may even lose some weight and, whether aesthetic vanities bother you or not, it’s always good to feel lighter...and here’s the bit I personally like least: if you haven’t already done so, give up smoking

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products