None listed
Conditions
Brief 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. .
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 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 as
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.
Sponsors
Dr. Malik Hassan Mehmood
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
26 Years to 70 Years
Healthy volunteers
No
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
Outcome results
None listed