| CTRI Number |
CTRI/2025/09/095419 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Acarbose on Blood Sugar Control and Cholesterol in Patients with Metabolic Syndrome in a North Indian Hospital |
|
Scientific Title of Study
|
The Effect of Acarbose on HBA1C and Lipid Profile in Patients with Metabolic Syndrome in Tertiary Care Hospital of North India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshad Sahu |
| Designation |
Junior Resident |
| Affiliation |
KPS institute of medicine, GSVM medical college, Kanpur |
| Address |
276 Damodar nagar Barra 2 Kanpur Nagar Uttar Pradesh (208027) Medicine department, KPS institute of medicine, GSVM Medical College, Kanpur nagar (208002) Kanpur Nagar UTTAR PRADESH 208027 India |
| Phone |
7376562196 |
| Fax |
|
| Email |
heythereharshad@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR JS Kushwaha |
| Designation |
professor |
| Affiliation |
KPS institute of medicine, GSVM medical college, Kanpur |
| Address |
Medicine office, Medicine department, KPS institute of medicine, GSVM medical college, Kanpur nagar (208002) Medicine office, Medicine department, KPS institute of medicine, GSVM medical college, Kanpur nagar (208002) Kanpur Nagar UTTAR PRADESH 208002 India |
| Phone |
07376562196 |
| Fax |
|
| Email |
drjskushwaha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR JS Kushwaha |
| Designation |
professor |
| Affiliation |
KPS institute of medicine, GSVM medical college, Kanpur |
| Address |
Medicine office, Medicine department, KPS institute of medicine, GSVM medical college, Kanpur nagar (208002) Medicine office, Medicine department, KPS institute of medicine, GSVM medical college, Kanpur nagar (208002) Kanpur Nagar UTTAR PRADESH 208002 India |
| Phone |
07376562196 |
| Fax |
|
| Email |
drjskushwaha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medicine office, Medicine department, KPS institute of medicine, GSVM medical college, Kanpur nagar (208002) |
|
|
Primary Sponsor
|
| Name |
Medicine department KPS institute of medicine GSVM medical college Kanpur Nagar |
| Address |
Medicine office, Medicine department, KPS institute of medicine, GSVM medical college, Kanpur nagar |
| Type of Sponsor |
Government medical college |
|
|
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 JS Kushwaha |
KPS institute of medicine, LLRH hospital |
Medicine office, Medicine department, KPS institute of medicine, GSVM medical college, Kanpur nagar Kanpur Nagar UTTAR PRADESH |
9140299745
drjskushwaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee GSVM medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E70-E88||Metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo |
| Intervention |
Tab Acarbose |
Tab Acarbose, an oral drug, initial dose will be 25 mg once daily which can be increased up to 50 to 100 mg thrice daily according to the weight of the patient and side effect profile. Total duration of intervention will be 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
newly diagnosed metabolic syndrome patient or patient taking oral anti diabetic agent or anti hypertensive drug
Able to attend follow up visit
Willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Allergy to Acarbose
Hepatic dysfunction or liver cirrhosis
Chronic intestinal disease related with digestive or absorption disorder
Intestinal obstruction
Intestinal ulcer, inflammatory intestinal disease
Severe renal impairment creatinine clearance less than 60 mL per min
Current or recent less than 3 months use of Acarbose
Currently on insulin therapy
Pregnancy or lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1C, triglycerides, HDL and non HDL C level, and percentage of patients meeting metabolic syndrome criteria reversal after the use of Acarbose |
base line and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in triglyceride, HDL, Non HDL C, Fasting blood glucose, ASL ALT levels after the use of Acarbose drug |
base line 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="274" Sample Size from India="274"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study aims to evaluate the effect of Acarbose on HbA1C and lipid profile in patients with metabolic syndrome in a tertiary care hospital in North India. Metabolic syndrome is a cluster of risk factors including abdominal obesity, insulin resistance, hypertension, dyslipidemia and impaired glucose metabolism, all of which increase the risk of type 2 diabetes and cardiovascular disease. Acarbose, an alpha glucosidase inhibitor, lowers postprandial hyperglycemia by delaying carbohydrate absorption and has also shown potential benefits in improving triglyceride and lipid levels. The primary objective is to assess changes in HbA1C, triglycerides, and non HDL cholesterol after 12 weeks of acarbose therapy, along with reversal of metabolic syndrome criteria. This randomized controlled trial will be conducted over 12 weeks on 274 patients at GSVM Medical College, Kanpur, between october 2025 and march 2026. Eligible participants are adults aged 30 to 65 years who meet at least three criteria for metabolic syndrome, either newly diagnosed or on stable oral antidiabetic agent with or without a single antihypertensive. Patients with hepatic disease, gastrointestinal disorders, severe renal impairment, insulin therapy, pregnancy, lactation, or recent acarbose use will be excluded. Participants will be divided into two groups that is Group A will receive acarbose and the standard of care, and Group B will receive only the standard of care. Baseline and follow-up assessments will include waist circumference, BMI, blood pressure, HbA1c, and lipid profile. Data will be analyzed using SPSS software, with statistical significance set at p less than 0.05. |