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

NCT ID: NCT03659461

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-01-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

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

Interventions

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Sitagliptin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Chong Shiau Chin

Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kamaruddin Nor Azmi

Role: STUDY_DIRECTOR

National University of Malaysia

Shiau Chin Chong

Role: PRINCIPAL_INVESTIGATOR

National University of Malaysia

Locations

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Hospital Sultan Ismail

Johor Bahru, Johor, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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UKM-22

Identifier Type: -

Identifier Source: org_study_id

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