Pilot Trial of Chromium-Metformin Combination in Type 2 Diabetes

Stopped early · Phase 1

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00332085

Run by

Bastyr University

People needed

40

Starts

2006-01-01

Expected to finish

2007-03-01

Last updated by the study team

2007-10-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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.

Where it is running

• Bastyr University Campus SPR — Kenmore, Washington, United States
• Bastyr Center for Natural Health — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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