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

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ClinicalTrials.gov Identifier: NCT02999841
Recruitment Status : Unknown
Verified December 2016 by Linong Ji, Peking University.
Recruitment status was:  Recruiting
First Posted : December 21, 2016
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Linong Ji, Peking University

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Obesity Drug: Acarbose Drug: Vildagliptin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose

Arm Intervention/treatment
Experimental: Group A
Acarbose
Drug: Acarbose
1-2 week: 50mg tid; 3-24 week: 100mg tid.
Other Name: Glucobay (Acarbose Tablets)

Active Comparator: Group B
Vildagliptin
Drug: Vildagliptin
1-24 week: 50mg bid
Other Name: Galvus (Vidagliptin Tablets)




Primary Outcome Measures :
  1. 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 Measures :
  1. Change of body weight in kilograms measured by investigators from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  2. Change of waist circumstance in centimeters measured by investigators from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  3. Change of body mass index in kg/m^2 measured by investigators from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  4. Change of the subcutaneous fat area in square centimeters assessed by abdominal CT scans from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  5. Change of hemoglobin A1c in percents from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  6. Change of hemoglobin fasting plasma glucose in millimols per liter from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  7. Change of hemoglobin 2-hour-post-prandial plasma glucose in millimols per liter from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  8. Change of triglyceride in millimols per liter from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  9. Change of total cholesterol in millimols per liter from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  10. Change of low-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  11. Change of high-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  12. Change of insulin in international units per liter from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  13. Change of brain natriuretic peptide in nanograms per milliliter from baseline to 24 weeks. [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999841


Contacts
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Contact: Linong Ji, MD +86 10 8832 4108

Locations
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China, Beijing
Beijing Pinggu Hospital Recruiting
Beijing, Beijing, China, 101200
Contact: Yufeng Li, MD    +86 139 1108 0328      
Principal Investigator: Yufeng Li, MD         
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Linong Ji, MD Peking University People's Hospital

Publications of Results:
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Responsible Party: Linong Ji, Director of Department of Endocrinology and Metabolism, Peking University People's Hospital., Peking University
ClinicalTrials.gov Identifier: NCT02999841     History of Changes
Other Study ID Numbers: 2119000273
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Do not share data.
Keywords provided by Linong Ji, Peking University:
Visceral fat
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Vildagliptin
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glycoside Hydrolase Inhibitors