NCT00332085

TerminatedPhase 1

Pilot Trial of Chromium-Metformin Combination in Type 2 Diab...

Bastyr University Source

Bastyr University

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

190

Study Type

interventional

Estimated enrollment

40

Locations

1 country

Sites

2

Timeline

Study Start

January 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

March 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Estimated enrollment: 40 participants
Study completion date: March 2007
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 30, 2006
Actual (reported)
First Posted
June 1, 2006
Actual (reported)
Study Completion
March 2007
Actual (reported)

Last Updated: October 31, 2007
Status Verified: October 2007
Last Update Submitted: October 29, 2007

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 PicolinateDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Bastyr University
Otherlead

Study Sites (2)

Bastyr University Campus SPR

Kenmore, Washington, 98036, United States

Bastyr Center for Natural Health

Seattle, Washington, United States

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

picolinic acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

March 2007

Actual (reported)

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Phase 1Completed

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Phase 1Completed

NCT00542698

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Phase 1Completed

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.

Contact the study team to confirm eligibility.

Last Updated

October 31, 2007

Record last verified: 2007-10

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00332085
Data provider: ClinicalTrials.gov
Source updated: 2007-10-31
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:52 UTC

Locations

US(2)

Study Stopped

Pilot Trial of Chromium-Metformin Combination in Type 2 Diabetes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations