CompletedPhase 2ACTRN12624000777594

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.


Sponsor

Dr. Malik Hassan Mehmood

Enrollment

140 participants

Start Date

Oct 5, 2022

Study Type

Interventional

Conditions

Summary

Chromium picolinate supplement was investigated as a potential adjuvant therapy for managing diabetes mellitus and its associated renal complications. This randomized single-blind clinical trial aimed to evaluate the efficacy and safety of Picomium in controlling HbA1c levels, improving serum creatinine and eGFR and mitigating other metabolic parameters in diabetes and diabetic-induced renally impaired patients. The study involved 45 days of treatment with Picomium tablets containing 500mcg of chromium picolinate administered once daily as an adjuvant to already prescribed anti-diabetic medications. Comprehensive clinical monitoring and assessment was conducted throughout the study, including the reporting of any adverse events. Treatment was well tolerated with no adverse effects dissimilar from control. Chromium picolinate supplement given as Picomium manufactured by Nutrix Healthcare, a leading pharmaceutical company based in Faisalabad, Pakistan. Picomium is a registered product with DRAP registration number DRAP-14935, indicating that it has been reviewed and approved by the Drug Regulatory Authority of Pakistan (DRAP) for sale in Pakistan. The findings of this trial contributes to the growing body of knowledge regarding the potential benefits of chromium picolinate supplementation in diabetes management. .


Eligibility

Sex: Both males and femalesMin Age: 26 YearssMax Age: 70 Yearss

Inclusion Criteria5

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

Exclusion Criteria8

  • Chromium Picolinate supplementation in lasst 90 days before the start of the trial in any form greater than or equal to 120µg/d.
  • Acute Conditions like stroke
  • Patients having hepatic diseases
  • Patients with Alcohol or drugs abuse
  • Issues with the subject's mental health that would prohibit them from finishing the
  • study
  • Female with pregnancy or breast feeding
  • Failure to give informed consent

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Participants in this group received a combination treatment of chromium picolinate alongside their existing hypoglycemic medications. Hypoglycemic agents dosage must be stable for at least 60 days pri

Participants in this group received a combination treatment of chromium picolinate alongside their existing hypoglycemic medications. Hypoglycemic agents dosage must be stable for at least 60 days prior to entering trial. This additional therapy involves administering a 500 µg chromium picolinate tablet once daily for an extended period of 45 days. To monitor compliance, participants were asked to bring all remaining tablets along with medication containers to their final visit. Adherence was assessed by counting the unused tablets and verifying the completeness of dosing records in their diaries.


Locations(1)

Punjab, Pakistan

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12624000777594


Related Trials