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

Type 2 Diabetes Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659711
• Other study ID #: 1931 Januvia
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: December 2013

Study information

• Verified date: June 2022
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Januvia (Sitagliptin) 100 mg
The first group will be started on 100 mg sitagliptin daily for 12 weeks
• Placebo
will be placed on a placebo for 12 weeks.

Locations

Country	Name	City	State
United States	115 Flint Road	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 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		12 weeks
Secondary	Change in Oxidative Stress From Baseline to 12 Weeks	To investigate that therapy with sitagliptin orally daily (100 mg) for 12 weeks decreases oxidized lipids (9-hydroxyoctadecadienoicacid (9-HODE) and 13-HODE) in plasma and F2-isoprostane in urine of obese type 2 diabetic patients; Outcome measures given are calculated from the baseline - 12 weeks.	value at 12 weeks minus value at baseline