Effect of Acarbose and Vildagliptin on Visceral Fat Distr... | NCT02999841

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

NCT02999841

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Dec 21, 2016Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Diabetes Mellitus, Type 2
Obesity

Interventions

Acarbose
Vildagliptin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Mar 15, 2016

First Submission Date that Met QC Criteria

Dec 18, 2016

First Posted Date

Dec 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2016

Last Update Posted Date

Dec 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Acarbose	Drug: Acarbose
Group B	Active Comparator	Vildagliptin	Drug: Vildagliptin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acarbose	Drug	1-2 week: 50mg tid; 3-24 week: 100mg tid.	Group A	Glucobay (Acarbose Tablets)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Linong Ji, MD	Contact	+86 10 8832 4108

Name	Affiliation	Role
Linong Ji, MD	Peking University People's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Pinggu Hospital	Recruiting	Beijing	Beijing Municipality	101200	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19656312	Result	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.
16112958	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D014312	Trisaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity