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NCT01709123 · ClinicalTrials.gov registry record · NA

Effects of Micronutrient (Chromium) Supplementation on Diabetes

A NA study, sponsored by Louisiana State University Health Sciences Center Shreveport.

Completed
Registry status
NA
Development phase
62
Enrollment target

NCT01709123: Completed NA study, sponsored by Louisiana State University Health Sciences Center Shreveport.

NCT01709123 is a NA study that has completed, run by Louisiana State University Health Sciences Center Shreveport. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01709123, a NA study, has completed, sponsored by Louisiana State University Health Sciences Center Shreveport.

COMPLETED
Registry status
NA
Development phase
62 participants
Enrollment target

Study Summary

6-8% of USA population has diabetes. Intensive blood glucose control dramatically reduces the devastating complications that result from poorly controlled diabetes. However, for many patients, achievement of tight glucose control is difficult with current regimens. Trivalent chromium, the form found in foods and dietary supplements, is believed to be safe. Our preliminary studies have reported that chromium supplementation inhibits the increase in pro-inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6; TNF-alpha and IL-6) secretion levels caused by high glucose levels in cultured monocytic cells. Similarly, animal studies have shown that chromium niacinate supplementation lowered blood levels of glycemia and pro-inflammatory cytokines in streptozotocin-treated diabetic rats. Cytokines are proteins that are secreted by monocytes and other cells in response to various stimuli, such as infection. Some of the cytokines are known to regulate insulin sensitivity and elevated level of these cytokines in blood may accelerate clogging of arteries. Thus, chromium supplementation may increase insulin sensitivity and glycemic control in diabetic patients, and may prevent the development of cardiovascular disease in diabetic patients. Given the enormous public health cost of diabetes, the prospect of being able to use a relatively low-cost dietary supplement, such as chromium, as an adjuvant therapy to help in achieving normal blood glucose level merits further study. We will examine the effects of placebo and chromium niacinate supplementation on the fasting glucose, cholesterol, triglycerides, and markers of vascular disease in blood of diabetic patients. We will determine these above parameters at baseline and after the 1, 2 and 3 months of supplementation in diabetic patients. The long-term objective is to explore the efficacy of chromium as an adjuvant treatment for better glycemic control, prevent the development of cardiovascular disease (CVD), and imp

Primary Outcome

Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group.

Interventions

  • DRUG placebo
  • DRUG chromium niacinate

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2007-08
Est. Completion 2013-09
Phase NA

What the finished NCT01709123 record still lists

NCT01709123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT01709123 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01709123 about?

NCT01709123 is a clinical study titled "Effects of Micronutrient (Chromium) Supplementation on Diabetes". 6-8% of USA population has diabetes. Intensive blood glucose control dramatically reduces the devastating complications that result from poorly controlled diabetes. However, for many patients, achievement of tight glucose control is difficult with current regimens. Trivalent chromium, the form found...

What is the current status of trial NCT01709123?

This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2007-08. Estimated completion is 2013-09.

What interventions are being tested in trial NCT01709123?

The interventions under investigation include: placebo (DRUG), chromium niacinate (DRUG).

Who is sponsoring clinical trial NCT01709123?

This trial is sponsored by Louisiana State University Health Sciences Center Shreveport, which has 40 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01709123's enrollment target sits among peer trials

62 1157th of 2000 higher than 837 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01709123, the US trial registry maintained by the National Library of Medicine. NCT01709123 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.