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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• PreDiabetes
• Type 2 Diabetes Mellitus

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