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Question:

From Washington, D.C., USA:

I have been asked to participate in a study of insulin growth factor (IGF) hormone to help determine whether IGF can help make insulin more effective. The study is described on the informed consent form I received as "A Phase III, randomized, double-blind, placebo-controlled, multicenter study of the combined effects of subcutaneously administered insulin and rhIGF-1 in subjects with insulin-dependent diabetes mellitus."

I am weighing the pros and cons of participating in such a trial. The financial incentive is not great. I would have to go in for blood and other tests ten times in the next year and follow a very strict regimen of injections (two injections of IGF in addition to the four insulin shots I already take). I would also have to monitor my diet even more closely than I already do. I would consider joining the study if I felt that the approval of IGF by the FDA was beneficial to diabetics, but have seen very little published research on this subject and I am also put off by the possible side effects listed in the informed consent. What is your opinion of the potential of IGF to increase the effectiveness of insulin in IDDM patients and the risk of side effects that use of this hormone poses?

Answer:

The diabetes program where I work is one of the study sites for the use of IGF in Type 1 diabetes, but I can't make the decision for you. You would not be asked to participate unless your team thought it would help with your control. While the financial "incentives" aren't great, several thousand dollars of medical care and supplies will be provided, to say nothing of the potential cost savings that might result from optimizing diabetes control if the product works as expected.

The manufacturers of any new pharmaceuticals, such as IGF, are required to conduct human studies before applying to the FDA for approval to sell their products in the USA. There's no way to ascertain the beneficial nature of these products without people volunteering to participate in randomized controlled clinical trials.

Ask the study personnel for copies of scientific articles about IGF; there was a whole issue of the Journal of Pediatric Endocrinology and Metabolism on this subject about 6 months ago.

SS

Original posting 19 Aug 97

  
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Last Updated: Tuesday April 06, 2010 15:08:54
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