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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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