Friday, December 7, 2012

How are volunteers selected to test a medicine in human clinical trials before it is released for sale?

Q. Do the volunteers already have some illness that there is a chance the medicine could cure in testing?
If so, for most illnesses (e.g. diabetes) medicines already exist that would be safer for the patient to use. Also the people who may look to untested medicines because no existing medicine works would not make up a reliable sample for people affected by the illness, right?

Are the volunteers given money? If so, how do they acquire the illness the medicine is designed to cure?

What is the main motivation for volunteering in human clinical trials?

A. Clinical trials are highly regulated by the FDA with a clear set of guidelines and procedures that must be followed. The selection of potential candidates must be clearly defined by a very specific criteria, which is in turn must also be approved by the FDA. This criteria largely depends on a number of factors, including the type of drug, age, lifestyle, etc.

Usually, there is two types of testing: compensated and uncompensated. The uncompensated is what most people are familiar with, which usually comes in the form of treating patients with a terminal illness or a disorder that currently has no effective treatments. The compensation for participation is being possibility of being cured or at least have improved symptoms instead of monetary values. The other form, compensated testing, is found typically in elective products, like cosmetics and weight loss pills, where the volunteer will get paid a certain amount upon completing the trial successfully and adhering to their protocols.

"How do they acquire the illness the medicine is designed to cure?" Humans aren't lab rats, so it is unethical and illegal to induce any condition that alter health of an individual negatively. Again, the individuals selected must either already have the condition the product is intended to treat or at least show clear signs that they can benefit from its use. In most cases, even the latter is not enough to volunteer.


Could you have undiagnosed type 2 Diabetes since childhood and not have any serious complications?
Q. I have been reading up on the symptoms of Diabetes and I had recurring lesions on my feet as a child that correspond with Diabetes but I never had it diagnosed. Could somebody have this condition for a long time and not have serious complications?.

A. Yes it is quite possible to have diabetes for quite some time before it is diagnosed and this is most especially true for type 2 diabetes. In most cases there is a 10 year lead-in time of pathological damage prior to the glucose being consistently elevated. Thus prompt diagnosis and decisive intervention is essential. I must say however that recurring lesions on the feet as a child would be an extremely unusual presentation for diabetes. This does not mean that you should not see your physician as every problem warrants a diagnosis in order to define a cure. It simply means that I would be really surprised if you have diabetes. If I may be of further assistance please let me know. I wish you the very best of health and happiness and in all things may God bless. JR


Could they have diagnosed me wrong with diabetes?
Q. I got tested for diabetes and the results came back border line, but not fully diabetic. Except now i think i am a full diabetic.

I have EXTREME thirst, fatigue, sometimes blurred vision, weakness, dry skin, charly horses almost everytime i sleep sometimes so bad i almost cry, and numb legs which used to get really bad at night when i lay on my stomache but have gotten less frequent.

A. It would have been helpful if you had provided more information most especially your glucose readings. When physicians use the term 'borderline' they are most often saying that you are an 'early' diabetic. Since the term borderline is - to my knowledge - never used in reference to type 1 diabetes I must assume that you have early type 2 diabetes. The initial approach is most often life-style modification rather than pharmacologic intervention. A low glycemic index diet with little to no refined carbohydrates, weight loss if you are over weight, and regular exercise. It would not be appropriate to suggest that you start taking a medication - such as metformin hydrochloride - as one respondent has suggested. This is because we do not know your glucose readings and if they are only mildly elevated - which is what I suspect - prescribing metformin might lead to hypoglycemia. The symptoms that you provide are not typical of type 2 diabetes. Yes diabetics may experience thirst, fatigue (although this is a common symptom even without diabetes), and blurred vision. Dry skin and muscle cramping however are not symptoms of diabetes. Numbness in the legs is potentially related to diabetes as diabetes may cause peripheral neuropathy. There is a qualifying comment. Peripheral neuropathy most often starts in the feet and gradually progresses to the legs which does not match your very limited description. My advice would be to return to your physician. Obtain the actual glucose result(s). Inquire about your symptoms. If your physician believes that they are related to diabetes then 'treating' the diabetes is the place to start. If your physician does not believe that they are related to diabetes then it is the physician's responsibility to determine the diagnosis in order to define the treatment. These symptoms sound as if they really interfere with your activities and sleep so I would pursue this until a physician has managed to relieve you symptoms. If I may be of further assistance please let me know. I wish you the very best of health and in all things may God bless.


How many grams of sugar is safe for a Type 2 diabetic?
Q. I want to help an adult friend who has type 2 diabetes eat the foods he likes.

He's been reading the nutritional facts, and he avoids foods that have more than 2 grams of sugar per serving.

How many grams of sugar should a diabetic consume? Of course, it's best that he doesn't consume any sugar at all, but please tell me the most amount of sugar a type 2 diabetic is allowed to consume.

A. David:

I wish Chadmg's answer where correct. Things will be SO much easier that way. Unfortunately, it is not. More boring, yes. But simpler and easier.

Now, I am personally thankfull it is this way (don't get me wrong). It is just that there ar so many people in this wotld that would benefit from it being the other way.

If you exterminate completely your friends sugars consumption, his blood sugar level will drop to 0 and you will certainly die. So he needs to eat the right amount of carbohydrates (sugars--more or less complex) for your body to use without collecting it all in his blood.

Even high power, high glycemic foods such like non diet chocolate milk can have a place in the life of a diabetic, in controlled amounts and under very special circumstances.

Say what?

Yes, you read it right.

The special circumstances are an hypoglycemia attack. And the required amount is 15 (perhaps up to 30) grams of carbohydrates.

A 200ml (6.7 oz) box of chocolate milk here contains 24 grams of carbohydrates (I read the label). Enough to push your friend's sugar level up by 80 mg/dL (4.4 mmol/L). Which is you are having a blood sugar level of 30 mg/dL (1.7 mmol/L), that will leave you at 110 (6.6), which is perfect.

Of course, you will also need to eat something more consistent such as a diet yogurt to keep it from going back down in 2 hours, which is how long those kind of sugars can push your glucose up.

Note how I did the calculations and how low the sugar level was to begin with.

The most is always defined by your glucometer and the following this formula:

=========================================
15 grams of carbohydrates = 50 mg/dL (2.8 mmol/L) rise
=========================================

According to this formula, 2 grams is way too low for him to avoid. He should try 15 grams.

Please note when I refer to carbohydrates, these don't mean fibers. Fibers are good. The more the better.

The reason is that fibers cannot be digested by our stomach, and they get defecated before reaching the blood. Indeed fibers might carry on some carbs with them to the excrement.

So, if you read that each portion of a food has 25 grams of carbs, but of them 20 are fibers, you can go and eat it without a problem.

Now, I am not a doctor. Talk to a doctor personally without applying any of this.

Moreover, if your doctor disqualifies me, then consider me disqualified. I am not a doctor, just a diabetic that knows from experience and conversations with lots of doctors and nutritionists and assisting to education talks doctors held.

If after this warning you still choose to disobey your doctor and obey me, don't blame me later for doing so. It could well be that this formula for some medical reason doesn't applies to your friend.

Now, I am type 1. For type 1s, you can also add a third factor to the equation:

15 grams of carbs = 50 mg/dL = 1 unit of insulin

But due to insulin resistance, this doesn't applies to type 2s. Howeverm if you measure how many insulin units drop you how much your friend's sugar level, he could get away with replacing his computed resistance level with the amount of of insulin your friend need to inject.

Note also that this relates specifically to insulin. In particular, to fast acting insulin (such as Humalog, ActRapid, etc). It does not apply to pills and does not apply to slower acting insulin with longer validity periods, such as Insulatard, any Mixtard, etc.





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