Pilot Trial of Chromium-Metformin Combination in Type 2 Diabetes

Launched by BASTYR UNIVERSITY · May 30, 2006

Keywords

ClinConnect Summary

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 a...

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.