Effect of supplementation of chromium in glucose of diabetic patients

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-79nxr8
• Date of registration: 08/10/2014
• Prospective Registration: No
• Primary sponsor: Universidade Feral do Rio Grande do Norte
• Public title: Effect of supplementation of chromium in glucose of diabetic patients
• Scientific title: Effect of Supplementation of Chromium Picolinate on blood glucose with Type 2 Diabetes
• Date of first enrolment: 11/11/2011
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-79nxr8
• Study type: Intervention
• Study design: Clinical trial of efetiveness, crossover, randomized controlled
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Ana Nunes Paiva
• Affiliation: Universidade Federal do Rio Grande do Norte

• Name: Ana Nunes Paiva
• Affiliation: Universidade Federal do Rio Grande do Norte

Key inclusion & exclusion criteria

Inclusion criteria: Volunteers diagnosed with type two diabetes mellitus according to the criteria of the American Diabetes Association two thousand and eleven; both genders; presenting glycated hemoglobin greater than or equal to seven percent; not in use of insulin; age between thirty and seventy years; not have taked mineral vitamin supplement in the last three months
Exclusion criteria: Volunteers taking insulin and / or corticosteroids; showing endocrinopathy (cushin syndrome; acromegaly; hyper or uncontrolled hypothyroidism); kidney disease; cancer; infection and anemia; pregnant women; lactating women



Age minimum: 30Y
Age maximum: 70Y
Gender: -

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

C18.452.394.750.149

Intervention(s)

P1 Group: 40 patients with type-2 diabetes, poorly controlled, will ingest a capsule containing 300 micrograms of chromium picolinate, twice daily (after breakfast and dinner), during 4 months. After this period, patients begin a new phase, in which they will ingest a capsule containing 120 milligrams of placebo (magnesium stearate, aerosil, microcrystalline cellulose and lactose), twice daily (after breakfast and dinner) , during 4 months.

P2 group: 40 patients with type-2 diabetes, poorly controlled, will ingest a capsule containing 120 milligrams of placebo (magnesium stearate, aerosil, microcrystalline cellulose and lactose), twice daily (after breakfast and dinner ), during 4 months. After this period, patients begin a new phase, in which they will ingest a capsule containing 300 micrograms of chromium picolinate, twice daily (after breakfast and dinner), during 4 months.

Throughout the intervention period, patients in both groups will continue in use of prescription drugs for the treatment of diabetes and receive nutritional counseling for the disease. The distribution of patients between the groups will be done in randomized order

Dietary supplement

J02.500.456

Primary Outcome(s)

The glycemic profile (fasting blood glucose, postprandial blood glucose and glycated hemoglobin) showed improvement after 4 months of supplementation with chromium picolinate, compared the differences between the groups

Improvement in glycemic control (fasting blood glucose, postprandial blood glucose and glycated hemoglobin), after 4 months of supplementation with chromium picolinate compared the differences between the groups

Secondary Outcome(s)

No improvement was found in the lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides)after 4 months of supplementation with chromium picolinate, compared the differences between the groups

Improvement in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides), after 4 and 8 months of supplementation with chromium picolinate compared the differences between the groups

Source(s) of Monetary Support

Universidade Feral do Rio Grande do Norte

Secondary Sponsor(s)

Universidade Federal do Rio Grande do Norte