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The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects

Information source: Kaleida Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Januvia (Sitagliptin) 100 mg (Drug); Placebo (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Kaleida Health

Official(s) and/or principal investigator(s):
Paresh Dandona, MD, Principal Investigator, Affiliation: Kaleida Health

Summary

Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in combination with metformin or a thiazolidinedione for control of type 2 diabetes mellitus. Sitagliptin has been shown to have fewer side effects in the control of blood glucose values. Obesity and diabetes are states of increased inflammation and can influence the free radicals and inflammatory markers (chemicals in the blood which increase due to inflammation in the body) and are also major risk factors for atherosclerotic disease. In this study we want to see the effect of sitagliptin on these markers. We believe that Sitagliptin may exert an anti-inflammatory effect in the human. The purpose of this study is to determine if the addition of sitagliptin to diabetic patients will provide added benefit. We believe that sitagliptin provides these added benefits by suppressing free radicals (charged substances that cause damage to the body) and inflammation.

Clinical Details

Official title: The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: To investigate that therapy with sitagliptin orally daily (100 mg) for 12 weeks decreases reactive oxygen species (ROS) generation by MNC, protein and mRNA expression of p47phox subunit of NADPH oxidase, in MNC's of obese type 2 diabetic patients

Secondary outcome: oxidative stress

Eligibility

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males or females with age 20-75 years inclusive.

- Type 2 diabetes

- Males and Females BMI > 30

- Subjects on statins, ACE inhibitors, thiazolidenediones and antioxidants will be

allowed as long as they are on stable doses of these compounds and the dosage in not changed during the course of study.

- BP under control -No change required to BP medications

- HbA1c > 7%

Exclusion Criteria:

- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery

bypass, surgery or coronary angioplasty) in the previous four weeks

- Pregnancy

- Hepatic disease (abnormal LFT's),Renal impairment (serum creatinine > 1. 5),

- Participation in any other concurrent clinical trial

- Any other life-threatening, non-cardiac disease,

- Uncontrolled hypertension (BP > 160/100 mm of Hg)

- Congestive Heart Failure

- Use of an investigational agent or therapeutic regimen within 30 days of study

- Subjects on Exenatide, incretin or insulin therapy

Locations and Contacts

115 Flint Road, Buffalo, New York 14221, United States
Additional Information

Starting date: March 2008
Last updated: December 17, 2012

Page last updated: August 23, 2015

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