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Effects of Glucose Lowering Agents in South Asian Women With Impaired Glucose Tolerance or Impaired Fasting Glucose

NCT04662866 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-04-08

No results posted yet for this study

Summary

This study will test the effect of four common oral anti-diabetic agents on hepatic insulin sensitivity in South Asian women with impaired glucose tolerance or impaired fasting glucose. In a 12-week, double-blind, randomized controlled intervention trial, the following drugs will be tested head-to-head: Metformin, Pioglitazone, Empagliflozin and Linagliptin. Additional, exploratory outcomes include whole body insulin sensitivity, insulin secretion and other markers of glucose and lipid metabolism, measured by the euglycemic clamp with stable isotope tracer dilution, indirect calorimetry and CT-measurements of abdominal adipose tissue compartment volumes and hepatic and pancreatic volume and attenuation.

The study is part of the DIASA - DIAbetes in South Asians - Research Programme, which aims to find ways to improve both prevention and treatment of type 2 diabetes in people of South Asian ethnicity.

Conditions

  • Impaired Glucose Tolerance
  • Insulin Sensitivity
  • Glucose Metabolism Disorders

Interventions

DRUG

Metformin capsule 500 mg, Empagliflozin encapsulated tablet 10 mg, Pioglitazone encapsulated tablet 30 mg, Linagliptin encapsulated tablet 5 mg

Comparison of 4 different antihyperglycemic drugs

Sponsors & Collaborators

  • The Research Council of Norway

    collaborator OTHER

  • Norwegian Diabetes Association

    collaborator OTHER

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • University Hospital, Akershus

    collaborator OTHER

  • Vestre Viken Hospital Trust

    collaborator OTHER

  • University of Glasgow

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Kåre I Birkeland, MD, PhD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2022-12-31
Completion
2023-10-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04662866 on ClinicalTrials.gov