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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; PreDiabetes
• Interventions: Drug: Sitagliptin

• Registration Number: NCT03659461
• Lead Sponsor: National University of Malaysia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-09-02
• Study First Posted: 2018-09-06
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-13
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low GLP-1 arm	Sitagliptin	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
normal GLP-1 arm	Sitagliptin	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

Primary Outcome Measures

Name	Time	Method
change in blood insulin response to sitagliptin	pre-treatment of sitagliptin and post 12-week treatment of sitagliptin	change from blood insulin response at 12 weeks
change in blood glucose load response to sitagliptin	pre-treatment of sitagliptin and post 12-week treatment of sitagliptin	change from blood glucose response at 12 weeks

Trial Locations

Locations (1)

Hospital Sultan Ismail; 🇲🇾 Johor Bahru, Johor, Malaysia