Effect of the Chromium Nicotinate on Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Universidade Federal de Goias.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Universidade Federal de Goias
ClinicalTrials.gov Identifier:
NCT01368328
First received: April 12, 2011
Last updated: June 6, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Goias:

Primary Outcome Measures:
  • Insulin Sensitivity as assessed with homeostatic model assessment (HOMA) [ Time Frame: baseline, 45 days and 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368328

Locations
Brazil
Goiania Municipal Health Departament
Goiânia, Goiás, Brazil, 74000000
Sponsors and Collaborators
Universidade Federal de Goias
Investigators
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Chromium
Niacin
Nicotinic Acids
Antimetabolites
Cardiovascular Agents
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements
Vasodilator Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 29, 2014