Pilot Trial of Chromium-Metformin Combination in Type 2 Diabetes

NCT00332085 | Terminated Phase 1

• 1 other identifier: 190
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Safety/Adverse Events

• Hemoglobin A1c

Secondary Outcomes (3)

• Fasting Blood Glucose, Fasting Insulin, HOMA Index

• Lipid Profile: total cholesterol, LDL, HDL, Triglycerides

• Oral Glucose Tolerance Test

Interventions

Chromium Picolinate DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Bastyr University: lead

Study Sites (2)

Bastyr University Campus SPR

Kenmore, Washington, 98036, United States

Location

Bastyr Center for Natural Health

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

picolinic acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ryan Bradley, ND

  Bastyr University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: June 1, 2006
• Study Start: January 1, 2006
• Study Completion: March 1, 2007
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

US (2)