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

NCT02999841 | Unknown Phase 4

• 1 other identifier: 2119000273
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Obesity

Keywords

Visceral fat

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (13)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Acarbose

Drug: Acarbose

Group B

ACTIVE COMPARATOR

Vildagliptin

Drug: Vildagliptin

Interventions

Acarbose DRUG

1-2 week: 50mg tid; 3-24 week: 100mg tid.

Also known as: Glucobay (Acarbose Tablets)

Group A

Vildagliptin DRUG

1-24 week: 50mg bid

Also known as: Galvus (Vidagliptin Tablets)

Group B

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ≤ Age ≤ 70 years old, male or female.
• HbA1c between 7% and 9% (7.0% ≤ HbA1c ≤9.0%).
• ≤ BMI ≤ 30 kg/m2.
• Written Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Pinggu Hospital

Beijing, Beijing Municipality, 101200, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 19656312 RESULT

• 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.

  PMID: 16112958 RESULT

• 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.

  PMID: 19515542 RESULT

• 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.

  PMID: 24030946 RESULT

• Yang X, Zhang X, Sun C, Zhao C, Kong X, Zhao M, Ji L, Li Y. Effect of acarbose and vildagliptin on plasma trimethylamine N-oxide levels in patients with type 2 diabetes mellitus: a 6-month, two-arm randomized controlled trial. Front Endocrinol (Lausanne). 2025 May 6;16:1575087. doi: 10.3389/fendo.2025.1575087. eCollection 2025.

  PMID: 40395816 DERIVED

• 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.

  PMID: 35930018 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Acarbose; Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Linong Ji, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linong Ji, MD

CONTACT

+86 10 8832 4108

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Endocrinology and Metabolism, Peking University People's Hospital.

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: December 21, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: December 21, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)