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NCT03659461 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

— GLP-1  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03659461
Other study ID # UKM-22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date January 31, 2020

Study information
Verified date March 2022
Source National University of Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 174
Est. completion date January 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sitagliptin
oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.

Locations
Country Name City State
Malaysia Hospital Sultan Ismail Johor Bahru Johor

Sponsors (1)
Lead Sponsor Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in blood glucose load response to sitagliptin change from blood glucose response at 12 weeks pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
Primary change in blood insulin response to sitagliptin change from blood insulin response at 12 weeks pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
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