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Clinical Trials/CTRI/2013/02/003417
CTRI/2013/02/003417RecruitingPhase 4

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

Drugs and Pharmaceutical Research Program under Technology development and transfer division0 sites3,000 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
3,000
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility 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

  • •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

Investigators

Sponsor
Drugs and Pharmaceutical Research Program under Technology development and transfer division

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