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

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02999841
• Other study ID #: 2119000273
• Status: Recruiting
• Phase: Phase 4
• First received: March 15, 2016
• Last updated: December 18, 2016
• Start date: March 2016
• Est. completion date: January 2018

Study information

• Verified date: December 2016
• Source: Peking University
• Contact: Linong Ji, MD
• Phone: +86 10 8832 4108
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Drug:
• Acarbose
1-2 week: 50mg tid; 3-24 week: 100mg tid.
• Vildagliptin
1-24 week: 50mg bid

Locations

Country	Name	City	State
China	Beijing Pinggu Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Review. — View 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 m — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the visceral fat area in square centimeter assessed by abdominal CT scans from baseline to 24 weeks.		24 weeks	No
Secondary	Change of body weight in kilograms measured by investigators from baseline to 24 weeks.		24 weeks	No
Secondary	Change of waist circumstance in centimeters measured by investigators from baseline to 24 weeks.		24 weeks	No
Secondary	Change of body mass index in kg/m^2 measured by investigators from baseline to 24 weeks.		24 weeks	No
Secondary	Change of the subcutaneous fat area in square centimeters assessed by abdominal CT scans from baseline to 24 weeks.		24 weeks	No
Secondary	Change of hemoglobin A1c in percents from baseline to 24 weeks.		24 weeks	No
Secondary	Change of hemoglobin fasting plasma glucose in millimols per liter from baseline to 24 weeks.		24 weeks	No
Secondary	Change of hemoglobin 2-hour-post-prandial plasma glucose in millimols per liter from baseline to 24 weeks.		24 weeks	No
Secondary	Change of triglyceride in millimols per liter from baseline to 24 weeks.		24 weeks	No
Secondary	Change of total cholesterol in millimols per liter from baseline to 24 weeks.		24 weeks	No
Secondary	Change of low-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.		24 weeks	No
Secondary	Change of high-density lipoprotein-cholesterol in millimols per liter from baseline to 24 weeks.		24 weeks	No
Secondary	Change of insulin in international units per liter from baseline to 24 weeks.		24 weeks	No
Secondary	Change of brain natriuretic peptide in nanograms per milliliter from baseline to 24 weeks.		24 weeks	No