Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with Type 2 diabetes with chromium picolinate and assessing the effect of the supplementation on insulin sensitivity as assessed with hyperinsulinemic clamps

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Chromium and Insulin Action

NCT00283777

Type 2 Diabetes

COMPLETED PHASE4

Chromium's Effect on Insulin Resistance in Obesity

NCT00997659

Insulin Resistance Obesity

COMPLETED NA

Chromium and Insulin Resistance

NCT00846248

Insulin Resistance

COMPLETED NA

Effect of the Chromium Nicotinate on Type 2 Diabetes

NCT01368328

Type 2 Diabetes

UNKNOWN PHASE3

Effects of Micronutrient (Chromium) Supplementation on Diabetes

NCT01709123

Diabetes Mellitus, Type 1

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Detailed Description:

The primary clinical strategy to improve metabolic control in patients with Type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention. However, alternative strategies, e.g. nutritional supplementation with over-the-counter agents, are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider. Unfortunately, considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports. As such, there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities.

One supplement that has attracted considerable clinical interest is chromium (Cr). However, routine use of Cr in subjects with diabetes is not currently recommended. In part, the controversy surrounding Cr supplementation stems from the lack of definitive randomized trials, the lack of "gold standard" techniques to assess glucose metabolism in the studies reported, the use of differing doses and formulation , and the study of heterogeneous study populations. As such, conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning Cr supplementation. In order to provide a comprehensive clinical evaluation of Cr, we conducted a randomized, double-blinded, placebo-controlled trial in subjects with Type 2 diabetes. Individuals had baseline measures consisting of oral glucose tolerance testing, body fat and adiposity assessed, and then used established techniques to assess insulin sensitivity with hyperinsulinemic-euglycemic clamps. Individuals were evaluated for 6 months at which time repeat testing was done.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chromium Picolinate

Chromium

Group Type EXPERIMENTAL

chromium picolinate 1000 mcg daily vs placebo

Intervention Type DIETARY_SUPPLEMENT

chromium picolinate 1000 mcg daily vs placebo

Placebo

Group Type OTHER

Placebo

Intervention Type OTHER

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

chromium picolinate 1000 mcg daily vs placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 2 diabetes
* On no meds to alter glucose metabolism
* age greater than 25 years old
* Fasting glucose greater than 125 mg/dl at screening

Exclusion Criteria

* Subjects on insulin
* Sujbects on meds that alter glucose metabolism
* Use of glitazones
* C0-existing disorders in major organ systems such as heart, kidneys, liver

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No