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Clinical Trials/CTRI/2025/11/096897
CTRI/2025/11/096897CompletedPhase 4

Effect of CoQ10 supplementation on glycemic and metabolic markers in Prediabetic Obese Patients in A Tertiary Care Hospital: A Double Blind, Randomized, Placebo Controlled Trial

DR SAI SANKAVI R1 site in 1 country76 target enrollmentStarted: December 1, 2025Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
76
Locations
1
Primary Endpoint
• Improvement in prediabetic state by estimating FBS, PPBS and HbA1c.

Study Overview

Brief Summary

Prediabetes is a reversible metabolic condition associated with insulin resistance, oxidative stress, and an increased risk of developing type 2 diabetes mellitus. Coenzyme Q10, an essential component of the mitochondrial electron transport chain and a potent antioxidant, may improve glycemic control and metabolic balance by enhancing mitochondrial efficiency and reducing oxidative stress.

This double blind, randomized, placebo controlled clinical trial aims to evaluate the effect of Coenzyme Q10 supplementation on glycemic and metabolic markers in prediabetic obese patients attending a tertiary care hospital. A total of 76 eligible participants aged 30 to 65 years with body mass index of 25 kg per square meter or greater will be randomly assigned in a 1:1 ratio to receive either Coenzyme Q10 100 mg once daily or a matching placebo for 12 weeks.

Primary outcomes include changes in fasting blood sugar, postprandial blood sugar, and HbA1c from baseline to 12 weeks. Secondary outcomes include changes in insulin resistance indices such as TyG index and TG HDL C ratio, leptin adiponectin levels, and quality of life assessed using the SF 36 questionnaire. The study aims to determine whether Coenzyme Q10 can improve glycemic control and metabolic health in prediabetic obese individuals.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • PREDIABETIC , OBESITY.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

• Improvement in prediabetic state by estimating FBS, PPBS and HbA1c.

Time Frame: • at 12 weeks

Secondary Outcomes

  • Improvement in insulin resistance by estimating TyG index, TG/HDL C ratio from baseline to 12 weeks

Investigators

Sponsor
DR SAI SANKAVI R
Sponsor Class
Other [SELF fund by the principal investigator]
Responsible Party
Principal Investigator
Principal Investigator

Dr Sai Sankavi R

SRM HOSPITAL GENERAL MEDICINE OPD

Study Sites (1)

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