Effect of Acarbose and Vildagliptin on Visceral Fat Distribution in Newly Diagnosed Type 2 Diabetes Patients
NCT ID: NCT02999841
Last Updated: 2016-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2016-03-31
2018-01-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Acarbose
Acarbose
1-2 week: 50mg tid; 3-24 week: 100mg tid.
Group B
Vildagliptin
Vildagliptin
1-24 week: 50mg bid
Interventions
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Acarbose
1-2 week: 50mg tid; 3-24 week: 100mg tid.
Vildagliptin
1-24 week: 50mg bid
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
30 Years
70 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Linong Ji
Director of Department of Endocrinology and Metabolism, Peking University People's Hospital.
Principal Investigators
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Linong Ji, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Beijing Pinggu Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Linong Ji, MD
Role: CONTACT
Phone: +86 10 8832 4108
Facility Contacts
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Yufeng Li, MD
Role: primary
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2119000273
Identifier Type: -
Identifier Source: org_study_id