Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Newly Diagnosed Type 2 Diabetes Patients (VISA-T2DM)

December 18, 2016 updated by: Linong Ji, Peking University

Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Overweight and Obesity Patients With Newly Diagnosed Type 2 Diabetes Mellitus: A Randomized Control Study

Focusing on newly diagnosed type 2 diabetes participants with overweight and obesity (24kg/m2 ≤ body mass index ≤ 30kg/m2).

50 participants per arm (acarbose & lifestyle combination / vildagliptin & lifestyle combination), using abdominal computed tomography scans and other methods to evaluate the effects of acarbose and vildagliptin on visceral fat distribution in overweight and obesity patients with newly diagnosed type 2 diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Linong Ji, MD
  • Phone Number: +86 10 8832 4108

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 101200
        • Recruiting
        • Beijing Pinggu Hospital
        • Contact:
          • Yufeng Li, MD
          • Phone Number: +86 139 1108 0328
        • Principal Investigator:
          • Yufeng Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients was diagnosed within the past 12 months with type 2 diabetes patients (WHO, 1999 criteria ).
  • Not received oral anti-diabetic drugs or has been on short-term(1month) treatment that had been discontinued 3 months before enrollment.
  • 30 ≤ Age ≤ 70 years old, male or female.
  • HbA1c between 7% and 9% (7.0% ≤ HbA1c ≤9.0%).
  • 24 ≤ BMI ≤ 30 kg/m2.
  • Written Informed consent.

Exclusion Criteria:

  • Subject with type 1 diabetes or gestational diabetes mellitus and other specific types DM.
  • Those who can not tolerate AGI or who is suffering GI disease.
  • Subject with repeated severe hypoglycemia and/or unawareness of hypoglycemia.
  • Known or suspected allergy to trial product(s) or related products.
  • Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial
  • Impaired liver function, defined as ALT≥2 or AST≥ 2 times upper referenced limit times upper normal limit.
  • Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, cancer, TB, acute infection.
  • Endocrine diseases (hypo thyroidism, hyperthyroidism,Cushing's syndrome).
  • Uncontrolled hypertension(SBP≥180mmHg and/or DBP≥100mmHg).
  • Diabetic ketoacidosis; or hyperosmolar non-ketotic coma.
  • Concomitant treatment which influences blood glucose and bodyweight.
  • Impaired renal function(Cr≥ 1.5 mg/dl in male or Cr≥1.4 mg/dl in female).
  • Mental disorders; drug or other substance misuse.
  • Participation in any drug clinical trials during the past 3 months before enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A
Acarbose
Drug: Acarbose
1-2 week: 50mg tid; 3-24 week: 100mg tid.
Other Names:
  • Glucobay (Acarbose Tablets)
ACTIVE_COMPARATOR: Group B
Vildagliptin
Drug: Vildagliptin
1-24 week: 50mg bid
Other Names:
  • Galvus (Vidagliptin Tablets)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of the visceral fat area in square centimeter assessed by abdominal CT scans from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of body weight in kilograms measured by investigators from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of waist circumstance in centimeters measured by investigators from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of body mass index in kg/m^2 measured by investigators from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of the subcutaneous fat area in square centimeters assessed by abdominal CT scans from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of hemoglobin A1c in percents from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of hemoglobin fasting plasma glucose in millimols per liter from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of hemoglobin 2-hour-post-prandial plasma glucose in millimols per liter from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of triglyceride in millimols per liter from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of total cholesterol in millimols per liter from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of low-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of high-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of insulin in international units per liter from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks
Change of brain natriuretic peptide in nanograms per milliliter from baseline to 24 weeks.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

December 18, 2016

First Posted (ESTIMATE)

December 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 18, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2119000273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Do not share data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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