Effect of the Chromium Nicotinate on Type 2 Diabetes
Recruitment status was Active, not recruiting
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Purpose
The role of micronutrients in diabetes is not well understood. Studies have demonstrated the relationship between low chromium serum levels and insulin resistance. This study aims to evaluate the effect of chromium nicotinate on increasing insulin sensitivity in patients with type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Dietary Supplement: Chromium nicotinate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Chromium Supplementation on Insulin Sensitivity in Patients With Type 2 Diabetes |
- Insulin Sensitivity as assessed with homeostatic model assessment (HOMA) [ Time Frame: baseline, 45 days and 90 days ] [ Designated as safety issue: No ]
- fasting triglycerides, high density lipoprotein cholesterol, low density lipoprotein cholesterol [ Time Frame: baseline, 45 days and 90 days ] [ Designated as safety issue: No ]
- body weight [ Time Frame: baseline, 45 days, 90 days ] [ Designated as safety issue: No ]
- body fat accessed with bioimpedance [ Time Frame: baseline, 45 days, 90 days ] [ Designated as safety issue: No ]
- waist circumference [ Time Frame: baseline, 45 days, 90 days ] [ Designated as safety issue: No ]
- urea and creatinine [ Time Frame: baseline, 45 days, 90 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 57 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Dietary Supplement: Chromium nicotinate
The intervention is offered during three months. There is a placebo group, chromium nicotinate 50 mcg group and chromium nicotinate 200 mcg group. Each patient is oriented to consume one capsule one hour after lunch and one capsule one hour after dinner.
|
| Active Comparator: Chromium nicotinate 50 mcg |
Dietary Supplement: Chromium nicotinate
The intervention is offered during three months. There is a placebo group, chromium nicotinate 50 mcg group and chromium nicotinate 200 mcg group. Each patient is oriented to consume one capsule one hour after lunch and one capsule one hour after dinner.
|
| Active Comparator: Chromium nicotinate 200 mcg |
Dietary Supplement: Chromium nicotinate
The intervention is offered during three months. There is a placebo group, chromium nicotinate 50 mcg group and chromium nicotinate 200 mcg group. Each patient is oriented to consume one capsule one hour after lunch and one capsule one hour after dinner.
|
Detailed Description:
Insulin is a hormone secreted by cells β of pancreatic islets in response to increased levels of glucose and serum amino acids. Insulin resistance means a decrease in the ability of insulin to stimulate glucose utilization because is disabled in the insulin receptor, decrease in concentration of receptors or failure mechanism of cell transit. Recently, the discovery of a substance called low molecular weight chromium-binding substance (LMWCr), showed the ability of this substance in amplifying insulin signaling, increasing the sensitivity of insulin receptors in the plasma membrane. This way, the capacity of LMWCr in activating the insulin receptor depends on levels of serum chromium. Thus, the hypothesis that the nutritional status of individual poor chromium contributes to the decrease in glucose tolerance and consequently, for type 2 Diabetes. Thus, it becomes necessary to assess the effect of supplementation of chromium in increased insulin sensitivity in patients with type 2 Diabetes. This is a double-blind randomized clinical trial, consisting of a period of three months of nutritional intervention with chromium nicotinate, biochemical and anthropometric evaluation and assessment of food profile and physical activity.
Eligibility| Ages Eligible for Study: | 30 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 2 diabetes
- Body mass index > 25 kg/m2
- Increased waist circumference
Exclusion Criteria:
- Subjects on insulin
- Pregnancy
- Patients with chronic complications as heart disease, nephropathy, retinopathy
Contacts and Locations| Brazil | |
| Goiania Municipal Health Departament | |
| Goiânia, Goiás, Brazil, 74000000 | |
| Principal Investigator: | Marília Mendonça Guimarães | Faculdade de Nutrição - Universidade Federal de Goiás |
| Principal Investigator: | Maria Sebastiana Silva | Faculdade de Educação Física - Universidade Federal de Goiás |
More Information
Additional Information:
Publications:
| Responsible Party: | Marília Mendonça Guimarães, Faculdade de Nutrição Universidade Federal de Goiás |
| ClinicalTrials.gov Identifier: | NCT01368328 History of Changes |
| Other Study ID Numbers: | DM2 |
| Study First Received: | April 12, 2011 |
| Last Updated: | June 6, 2011 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Universidade Federal de Goias:
|
Type 2 Diabetes Chromium Insulin resistance |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperinsulinism Chromium Niacin Nicotinic Acids Trace Elements Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vitamin B Complex Vitamins |
ClinicalTrials.gov processed this record on May 19, 2013