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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 is a NA study that has completed, run by Louisiana State University Health Sciences Center Shreveport. The registered enrollment target is 62 participants.
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
Interventions
- DRUG placebo
- DRUG chromium niacinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2007-08 |
| Est. Completion | 2013-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01709123
The ClinicalTrials.gov registry entry for NCT01709123 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Louisiana State University Health Sciences Center Shreveport, which has 40 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01709123 reports 0 study locations.
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.
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