Pilot Trial of Chromium-Metformin Combination in Type 2 Diabetes
|ClinicalTrials.gov Identifier: NCT00332085|
Recruitment Status : Terminated (Issues w/recruitment)
First Posted : June 1, 2006
Last Update Posted : October 31, 2007
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Chromium Picolinate||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Pilot Trial of Chromium-Metformin Combination in Type 2 Diabetes: Impact on Blood Sugar Control and Insulin Resistance|
|Study Start Date :||January 2006|
|Actual Study Completion Date :||March 2007|
- Safety/Adverse Events
- Hemoglobin A1c
- Fasting Blood Glucose, Fasting Insulin, HOMA Index
- Lipid Profile: total cholesterol, LDL, HDL, Triglycerides
- Oral Glucose Tolerance Test
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332085
|United States, Washington|
|Bastyr University Campus SPR|
|Kenmore, Washington, United States, 98036|
|Bastyr Center for Natural Health|
|Seattle, Washington, United States|
|Principal Investigator:||Ryan Bradley, ND||Bastyr University|