Status:
TERMINATED
Pilot Trial of Chromium-Metformin Combination in Type 2 Diabetes
Lead Sponsor:
Bastyr University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 alr...
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 su...
Eligibility Criteria
Inclusion
- ICD-9 Diagnosis of TYpe 2 Diabetes (250.XX) for two years or less and treated with metformin Patients having completed dose titration of metformin as prescribed by their physician and have reached a stble dose between 1000-2550 mg per day for at least two months HbA1c: 7.0-10.5%
Exclusion
- Duration of metformin treatment longer than 1 year at start time of study medication Historical or current use of oral anti-diabetes (OAD) medication (other than metformin) or use of insulin History ofmyocardial infarction within the lat 6 months, unstable angina, uncontrollable hypertension with systolic greater than 180 or diastolic greater than 110.
- Clinical or objective finding suggestive of congestive heart failure. Individuals not receiving routine management by their primary car eproviders and/or endocrinologists for their type 2 diabetes, including routine ECG and ophthamological evaluations.
- Women of child-bearing age not using standard birth control measures. Hemoglobin \<11 or \> 16; Hematocrig \<32 or \> 50; WBC \<3,000 or \>12,000; Platelets \<150,000 or \>500,000 Serum Creatinine \>1.4 mg/dL; BUN \>25 mg/dL Presence of greater than +1 protein on random macroscopic urinalysis at screening without a rule out of microalbuminuria Total bilirubin \>1.5 mg/dL LFTs: AST\>60 IU/L; ALT\>65/L; Alkaline phosphatase \>120 Iu/L. Isolated LFT elevations with an ultrasound diagnosis of non-alcoholic Steatohepatitis and a lab rule out of viral hepatitis will be included in the study with careful monitoring of LFTs.
- Subjects currently taking nutritional supplements, including multivatmin for study duration; subjects will be asked to discontinue any nutritional supplementation at the screening telephone interview 1 week prior to screening lab work and 4 week sprior to baseline lab work.
- Subjects taking lipid lowering medications except statins (i.e. niacin, fibrates, resins) due to possible chromium binding.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00332085
Start Date
January 1 2006
End Date
March 1 2007
Last Update
October 31 2007
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Bastyr University Campus SPR
Kenmore, Washington, United States, 98036
2
Bastyr Center for Natural Health
Seattle, Washington, United States