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Completed

NCT Number: NCT00659711

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

115 Flint Road

Buffalo, New York, 14221, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Januvia (Sitagliptin) 100 mg

Drug

The first group will be started on 100 mg sitagliptin daily for 12 weeks

Other names: januvia

Placebo

Drug

will be placed on a placebo for 12 weeks.

Primary outcomes

  1. 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

    Time frame: 12 weeks

Secondary outcomes

  1. Change in Oxidative Stress From Baseline to 12 Weeks

    Time frame: value at 12 weeks minus value at baseline

    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.

Sponsors and collaborators

Lead sponsor

University at Buffalo

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Acronym: 1928

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2008
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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