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

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Acarbose
Vildagliptin
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Visceral fat

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Pinggu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Acarbose

Vildagliptin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2016
Last Updated
December 18, 2016
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT02999841
Brief Title
Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Newly Diagnosed Type 2 Diabetes Patients
Acronym
VISA-T2DM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity
Keywords
Visceral fat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Acarbose
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Vildagliptin
Intervention Type
Drug
Intervention Name(s)
Acarbose
Other Intervention Name(s)
Glucobay (Acarbose Tablets)
Intervention Description
1-2 week: 50mg tid; 3-24 week: 100mg tid.
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Other Intervention Name(s)
Galvus (Vidagliptin Tablets)
Intervention Description
1-24 week: 50mg bid
Primary Outcome Measure Information:
Title
Change of the visceral fat area in square centimeter assessed by abdominal CT scans from baseline to 24 weeks.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change of body weight in kilograms measured by investigators from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of waist circumstance in centimeters measured by investigators from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of body mass index in kg/m^2 measured by investigators from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of the subcutaneous fat area in square centimeters assessed by abdominal CT scans from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of hemoglobin A1c in percents from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of hemoglobin fasting plasma glucose in millimols per liter from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of hemoglobin 2-hour-post-prandial plasma glucose in millimols per liter from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of triglyceride in millimols per liter from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of total cholesterol in millimols per liter from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of low-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of high-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of insulin in international units per liter from baseline to 24 weeks.
Time Frame
24 weeks
Title
Change of brain natriuretic peptide in nanograms per milliliter from baseline to 24 weeks.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linong Ji, MD
Phone
+86 10 8832 4108
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linong Ji, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Pinggu Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yufeng Li, MD
Phone
+86 139 1108 0328
First Name & Middle Initial & Last Name & Degree
Yufeng Li, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Do not share data.
Citations:
PubMed Identifier
19656312
Citation
Ibrahim MM. Subcutaneous and visceral adipose tissue: structural and functional differences. Obes Rev. 2010 Jan;11(1):11-8. doi: 10.1111/j.1467-789X.2009.00623.x. Epub 2009 Jul 28.
Results Reference
result
PubMed Identifier
16112958
Citation
Schernthaner GH, Schernthaner G. Insulin resistance and inflammation in the early phase of type 2 diabetes: potential for therapeutic intervention. Scand J Clin Lab Invest Suppl. 2005;240:30-40. doi: 10.1080/00365510500236119.
Results Reference
result
PubMed Identifier
19515542
Citation
Monami M, Iacomelli I, Marchionni N, Mannucci E. Dipeptydil peptidase-4 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis. 2010 May;20(4):224-35. doi: 10.1016/j.numecd.2009.03.015. Epub 2009 Jun 9.
Results Reference
result
PubMed Identifier
24030946
Citation
Kodama N, Tahara N, Tahara A, Honda A, Nitta Y, Mizoguchi M, Kaida H, Ishibashi M, Abe T, Ikeda H, Narula J, Fukumoto Y, Yamagishi S, Imaizumi T. Effects of pioglitazone on visceral fat metabolic activity in impaired glucose tolerance or type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Nov;98(11):4438-45. doi: 10.1210/jc.2013-2920. Epub 2013 Sep 12.
Results Reference
result
PubMed Identifier
35930018
Citation
Zhang X, Ren H, Zhao C, Shi Z, Qiu L, Yang F, Zhou X, Han X, Wu K, Zhong H, Li Y, Li J, Ji L. Metagenomic analysis reveals crosstalk between gut microbiota and glucose-lowering drugs targeting the gastrointestinal tract in Chinese patients with type 2 diabetes: a 6 month, two-arm randomised trial. Diabetologia. 2022 Oct;65(10):1613-1626. doi: 10.1007/s00125-022-05768-5. Epub 2022 Aug 5.
Results Reference
derived

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Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Newly Diagnosed Type 2 Diabetes Patients

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