Restudy of the PURSE HIS Population for the prevalence of risk factors causing blood vessel damage to heart muscle, brain tissue or peripheral tissue and to give advice on Diet, exercise and if necessary small dose of drug to prevent conversion of Pre-Diabetes to Diabetes

Phase 4

• Conditions: Health Condition 1: null- PreDiabetesDiabetesNormoglycemics

• Registration Number: CTRI/2013/02/003417
• Lead Sponsor: Drugs and Pharmaceutical Research Program under Technology development and transfer division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 3000

Inclusion Criteria

Inclusion: (from Phase I of PURSE HIS STUDY)

1.Normoglycemic group:

Fasting blood sugar less than 95mgperdl and 2 hour Glucose tolerance test less than 140 mgperdl

2.Pre-Diabetes group:

Participants under the category of

Impaired glucose tolerance IGT (2 hour Glucose tolerance test 141 to 199 mgperdl) or

Impaired Fasting Glucose IFG (Fasting Plasma Glucose between 95 to 125 mgperdl) or

Both IFG and IGT

3.Diabetes group:

Fasting blood sugar more than 125mgperdl and/or 2 hour Glucose tolerance test more than 199 mgperdl

Exclusion Criteria

Any of the following is regarded as a criterion for exclusion from the study:

1. History of serious adverse effect or hypersensitivity reactions to the medication used in the treatment of subjects in any arm of the study.

2. Pregnant women and breast feeding

3. History of malignancy

4. Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT greater than1.5times ULN.

5. Uncontrolled serum CK greater than3 times ULN

6. Serum creatinine greater than 2.5mg/dl

7. Participation in another investigational drug trial within the previous 4 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achieving the target level of reduction of the risk factors: <br/ ><br>1 Preventing conversion of Normoglycemics to Diabetes <br/ ><br>2 Preventing conversion of Pre-diabetes to Diabetes <br/ ><br>3 Preventing complications of Diabetes by proper control <br/ ><br>Timepoint: three years

Secondary Outcome Measures

Name	Time	Method
Preventing the development of complications (Vasculopathy, Neuropathy, Nephropathy) due to diabetesTimepoint: 3 years