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

Phase 4

• Conditions: Diabetes Mellitus, Type 2; Obesity
• Interventions: Drug: Vildagliptin; Drug: Acarbose

• Registration Number: NCT02999841
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-15
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-18
• Last Update Submitted: 2016-12-18
• Study First Posted: 2016-12-21
• Last Update Posted: 2016-12-21
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Vildagliptin	Vildagliptin
Group A	Acarbose	Acarbose

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Pinggu Hospital; 🇨🇳 Beijing, Beijing, China