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

Population study of Urban, Rural and Semi-urban regions for the detection of Endovascular disease and prevalence of risk factors and Holistic Intervention Study Phase II - PURSE-HIS Phase II

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003417

Enrollment

3000

Registered

2013-02-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- PreDiabetes Diabetes Normoglycemics

Interventions

Intervention1: for Normoglycemics: Diet and Excercise Intervention2: for Pre-Diabetics: Diet and Exercise (for six weeks) If not reduced then, Modern Medicine : Low dose of Metformin 250mg per day or

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Achieving the target level of reduction of the risk factors: 1 Preventing conversion of Normoglycemics to Diabetes 2 Preventing conversion of Pre-diabetes to Diabetes 3 Preventing complications of Diabetes by proper control Timepoint: three years	—

Secondary

Measure	Time frame
Preventing the development of complications (Vasculopathy, Neuropathy, Nephropathy) due to diabetesTimepoint: 3 years	—

Countries

India

Contacts

Public ContactDr S Thanikachalam

Sri Ramachandra University

stsrmc@yahoo.com04424766991

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026