Glucagon-like Peptide-1 Levels, Insulin Resistance and Insulin Sensitivity Index in Type 2 Diabetes Mellitus (GLP-1)

March 13, 2022 updated by: Chong Shiau Chin, National University of Malaysia

Comparative Study of Incretin System in Three Ethnic Groups With Abnormal Glucose Tolerance

This study is conducted to examine GLP-1, insulin resistance and insulin sensitivity portfolio in Malay, Chinese and Indian populations in Malaysia and to study the effect of DPPIV inhibitor in T2DM patients with different GLP-levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Johor
      • Johor Bahru, Johor, Malaysia, 81100
        • Hospital Sultan Ismail

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects are newly diagnosed of T2DM according to World Health Organisation criteria) and do not receive any glucose-lowering drugs
  • Subjects with normal glucose tolerance test according to World Health Organisation criteria which is carried out immediately before inclusion in the study
  • Subjects who are willing to participate and sign the informed consent form

Exclusion Criteria:

  • Patients with pre-existing T2DM
  • Patients with family history of diabetes
  • Patients receiving glucose-lowering medications
  • Patients with anemia, abnormal serum creatinine level, macroalbuminuria, proliferative retinopathy, impaired liver function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: low GLP-1 arm
Subjects are required to take oral 100mg Sitagliptin (Januvia) daily before breakfast for 12 weeks. 100mg is the recommended treatment dose. During the treatment with Januvia, subjects are not allowed to take any other medications except metformin
Drug: Sitagliptin
oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.
ACTIVE_COMPARATOR: normal GLP-1 arm
Subjects are required to take oral 100mg Sitagliptin ( Januvia) daily before breakfast for 12 weeks. 100mg is the recommended treatment dose. During the treatment with Januvia, subjects are not allowed to take any other medications except metformin
Drug: Sitagliptin
oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in blood glucose load response to sitagliptin
Time Frame: pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
change from blood glucose response at 12 weeks
pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
change in blood insulin response to sitagliptin
Time Frame: pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
change from blood insulin response at 12 weeks
pre-treatment of sitagliptin and post 12-week treatment of sitagliptin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Study Director: Kamaruddin Nor Azmi, National University of Malaysia
  • Principal Investigator: Shiau Chin Chong, National University of Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

January 31, 2020

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

September 2, 2018

First Posted (ACTUAL)

September 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 13, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKM-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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