Effects of chromium picolinate as an adjuvant on HbA1c levels in diabetic patients, and on eGFR and serum creatinine levels in diabetes induced renal impaired patients.

Phase 2

Completed

• Conditions: Diabetes; Diabetes Induced Renal Impairment; Metabolic and Endocrine - Diabetes; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12624000777594
• Lead Sponsor: Dr. Malik Hassan Mehmood

Brief Summary

A 45-day prospective randomized clinical trial investigated the effects of chromium picolinate supplementation in diabetic patients and those with diabetes-induced renal impairment. With 100 participants evenly splited between control and supplemented groups, the study showed significant improvements in glycemic control and diabetes-induced renal impairment in the chromium group. This group exhibited significant reductions in HbA1c and RBS levels, along with enhanced renal function indicated by reduced serum creatinine and increased eGFR. Additionally, chromium supplementation positively impacted HDL levels and showed potential in reducing LDL levels, suggesting implications for cardiovascular health. The study also noted benefits in weight management and blood pressure, attributing these effects to improved insulin sensitivity, glucose metabolism, and reduced renin-angiotensin system activity. The control group did not receive a placebo, which could introduce a placebo effect in the chromium-supplemented group, potentially skewing the results. The study period was 45 days, which might not be long enough to observe the long-term effects or potential side effects of chromium picolinate supplementation. Some benefits or risks might only manifest over extended periods. It is recommended to do future studies with more extended durations and different dosages to further validate these findings and explore long-term implications.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-15
• Study Start: 2024-06-25
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Men and Women 26 - 70 years old
2) Patients having HBA1C greater than 7.0%
3) Diagnosis of type-2 DM greater than or equal to 12 months
4) Patients currently taking anti-diabetic drugs (ADD), stable for greater than or equal to 60 days prior to entry
5) Patients who give informed consent

Exclusion Criteria

The exclusion criteria for the participants were as follow
1) Chromium Picolinate supplementation in lasst 90 days before the start of the trial in any form greater than or equal to 120µg/d.
2) Acute Conditions like stroke
3) Patients having hepatic diseases
4) Patients with Alcohol or drugs abuse
5) Issues with the subject's mental health that would prohibit them from finishing the
study
6) Female with pregnancy or breast feeding
7) Failure to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin (HbA1c) concentration was determined as a percentage of total hemoglobin using Cobas b 101. test system. [ At baseline and at 45 days post intervention commencement. ];Serum creatinine concentration was determined quantitatively in milligrams per deciliter (mg/dL) using a Roche Cobas Analyzer employing the Jaffé Gen.2 kinetic colorimetric assay. In this method, creatinine reacts with picric acid under alkaline conditions to form a yellow-orange complex, with the rate of color formation proportional to creatinine concentration. [ At baseline and at 45 days post intervention commencement. ];Participants eGFR was assessed by using the Cockcroft-Gault equation. <br>For male participants: eGFR = 175*((creatinine)^-1.154)*((age)^-0.203) <br>For female participants: eGFR = = 175*((creatinine)^-1.154)*((age)^-0.203)*0.742[ At baseline and at 45 days post intervention commencement. ]