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临床试验/CTRI/2025/11/096897
CTRI/2025/11/096897已完成4 期

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 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
• Improvement in prediabetic state by estimating FBS, PPBS and HbA1c.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • PREDIABETIC , OBESITY.

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: • at 12 weeks

次要结局

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

研究者

发起方
DR SAI SANKAVI R
申办方类型
Other [SELF fund by the principal investigator]
责任方
Principal Investigator
主要研究者

Dr Sai Sankavi R

SRM HOSPITAL GENERAL MEDICINE OPD

研究点 (1)

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