Type 2 Diabetes Clinical Trial
Official title:
Pilot Trial of Chromium-Metformin Combination in Type 2 Diabetes: Impact on Blood Sugar Control and Insulin Resistance
This pilot trial seeks to gather preliminary data on the combination of chromium picolinate, the most commonly used form of chromium, and metformin. The trial will recruit type 2 diabetes subjects already on metformin and treat them with chromium for 8 weeks. The results of this trial will provide vital preliminary data including safety and size of effect to direct future studies.
Chromium is widely marketed for use in diabetes and is used as a dietary supplement by
approximately 10 million US consumers, second only to calcium supplementation. Limited
scientific research has supported the potential of chromium to be beneficial in diabetes to
improve blood sugar control and insulin sensitivity, yet many of these studies have design
flaws and the relevance of the research in the US population has been questioned. Research
on use of complementary & alternative medicine (CAM) suggests as many as 40% use CAM in
combination with conventional medicine. Research performed at the Bastyr Center for Natural
Health suggests 69% of patients get chromium as part of their treatment and 45% are on oral
medications for blood sugar control. Metformin is the most commonly prescribed oral
medication for diabetes in the world. The combination of chromium and metformin has never
been studied in a clinical trial despite frequent use in combination. Additionally, research
suggests chromium and metformin share at least one mechanism of action leading to questions
about possible interactions - both favorable and unfavorable - resulting from the
combination.
Type 2 diabetes remains the sixth leading cause of death in the US. Despite evolving
technology and development of new medications, epidemiological data shows that only 37% of
patients are in good glycemic control as defined by the American Diabetes Association.
Recent large trials (UKPDS) suggest that any improvement in blood sugar control leads to
favorable outcomes.
Human research suggests chromium improves insulin receptor sensitivity leading to blood
sugar reduction. Research also shows blood levels of chromium are lower in people with type
2 diabetes and diabetic patients lose more chromium in their urine than people without
diabetes.
This pilot trial will recruit type 2 diabetic subjects already on metformin and treat them
with chromium picolinate for 8 weeks. The results of the trial will provide vital
preliminary data including safety and size of effect to direct future, larger studies.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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