| CTRI Number |
CTRI/2025/11/096897 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of coenzyme Q10 supplements on blood sugar and metabolic markers in obese, overweight patients with pre-diabetes in a hospital” |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Sankavi R |
| Designation |
Post graduate |
| Affiliation |
SRM HOSPITAL GENERAL MEDICINE OPD |
| Address |
SRM medical college hospital and research center
1ST floor medical college block
Department of pharmacology
post graduate room
Chennai
TAMIL NADU
603203
India |
| Phone |
9597908321 |
| Fax |
|
| Email |
ss4838@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sai Sankavi R |
| Designation |
Post graduate |
| Affiliation |
SRM HOSPITAL GENERAL MEDICINE OPD |
| Address |
SRM medical college hospital and research center
1st floor medical college block
Department of pharmacology
postgraduate room
Chennai
TAMIL NADU
603203
India |
| Phone |
9597908321 |
| Fax |
|
| Email |
ss4838@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Sankavi R |
| Designation |
Post graduate |
| Affiliation |
SRM HOSPITAL GENERAL MEDICINE OPD |
| Address |
SRM medical college hospital and research center
1st floor medical college block
Department of pharmacology
postgraduate room
Chennai
TAMIL NADU
603203
India |
| Phone |
9597908321 |
| Fax |
|
| Email |
ss4838@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM medical college hospital and research center
kattankulathur campus
chengalpattu district
Tamil Nadu 603203
INDIA |
|
|
Primary Sponsor
|
| Name |
DR SAI SANKAVI R |
| Address |
SRM medical college hospital and research center
1st floor medical college block
Department of pharmacology
postgraduate room |
| Type of Sponsor |
Other [SELF fund by the principal investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SAI SANKAVI R |
SRM MRDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
DEPARTMENT OF PHARMACOLOGY
1ST FLOOR MEDICAL COLLEGE BLOCK
PG ROOM
Chennai
TAMIL NADU |
9597908321
sathyaparthi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CoQ10 |
CoQ10 supplementation in prediabetic obese patients will lead to significant improvements in metabolic parameters, ultimately leading to improved health outcomes in the target population compared to placebo. |
| Comparator Agent |
placebo |
placebo |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
PREDIABETIC , OBESITY |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Improvement in prediabetic state by estimating FBS, PPBS and HbA1c. |
• at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in insulin resistance by estimating TyG index, TG/HDL C ratio from baseline to 12 weeks
Improvement in leptin adiponectin levels
Improvement in Quality of life assessed by questionnaire Shortform Health Survey SF36
|
baseline to 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |