Glucagon-like Peptide-1 Levels, Insulin Resistance and Insulin Sensitivity Index in Type 2 Diabetes Mellitus (GLP-1)
Primary Purpose
Type 2 Diabetes Mellitus, PreDiabetes
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Sitagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Hospital Sultan Ismail
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
low GLP-1 arm
normal GLP-1 arm
Arm Description
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
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
Outcomes
Primary Outcome Measures
change in blood glucose load response to sitagliptin
change from blood glucose response at 12 weeks
change in blood insulin response to sitagliptin
change from blood insulin response at 12 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT03659461
First Posted
August 29, 2018
Last Updated
March 13, 2022
Sponsor
National University of Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT03659461
Brief Title
Glucagon-like Peptide-1 Levels, Insulin Resistance and Insulin Sensitivity Index in Type 2 Diabetes Mellitus
Acronym
GLP-1
Official Title
Comparative Study of Incretin System in Three Ethnic Groups With Abnormal Glucose Tolerance
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, PreDiabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low GLP-1 arm
Arm Type
Experimental
Arm Description
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
Arm Title
normal GLP-1 arm
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.
Primary Outcome Measure Information:
Title
change in blood glucose load response to sitagliptin
Description
change from blood glucose response at 12 weeks
Time Frame
pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
Title
change in blood insulin response to sitagliptin
Description
change from blood insulin response at 12 weeks
Time Frame
pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamaruddin Nor Azmi
Organizational Affiliation
National University of Malaysia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shiau Chin Chong
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
81100
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Glucagon-like Peptide-1 Levels, Insulin Resistance and Insulin Sensitivity Index in Type 2 Diabetes Mellitus
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