Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332085
Status:
TERMINATED
Last Update Posted:
2007-10-31
First Post:
2006-05-30
Brief Title:
Pilot Trial of Chromium-Metformin Combination in Type 2 Diabetes
Sponsor:
Bastyr University
Organization:
Bastyr University
Study Overview
Official Title:
Pilot Trial of Chromium-Metformin Combination in Type 2 Diabetes Impact on Blood Sugar Control and Insulin Resistance
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Issues wrecruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None