1971: The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects
Study Details
Study Description
Brief Summary
This is a single center, prospective randomized double blind, parallel and placebo controlled study to evaluate oxidative stress and inflammation before and after treatment with linagliptin for 12 weeks. We will also, testing whether Linagliptin is an insulin sensitizer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Patients will be treated for 12 weeks with placebo once daily |
Drug: Placebo
|
| Active Comparator: Linagliptin 5mg per day Patients will be treated for 12 weeks with Linagliptin 5mg once daily. |
Drug: Linagliptin
Other Names:
|
Outcome Measures
Primary Outcome Measures
- change in JNK-1 protein in MNC before and after linagliptin use as compared to placebo. [12 weeks]
Secondary Outcome Measures
- change in inflammatory mediators in serum and adipose tissue following 12 weeks of treatments compared to placebo. [12 weeks]
- change in inflammation and oxidative stress following a single does of linagliptin. [12 Weeks]
- change in insulin sensitivity following linagliptin treatment compared to placebo. [12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
Age 20-80 years inclusive. Type 2 diabetes BMI ≥30 kg/m2 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.
HbA1c ≤ 8.0%
Exclusion Criteria:
- Use of GLP-1 agonists or DPP-IV therapy in the last 3 months. History of Pancreatitis. Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and hypertriglyceridemia.
Subjects who are taking antiplatelet or anticoagulant medications will be excluded from the fat biopsy portion of the study.
Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks Hepatic disease (liver function tests more than 3 times the upper limit of normal) Renal impairment (serum eGFR <30 ml/min) Any other life-threatening, non-cardiac disease Uncontrolled hypertension (BP > 160/100 mm of Hg) Congestive Heart Failure class III or IV. Use of an investigational agent or therapeutic regimen within 30 days of study Participation in any other concurrent clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ECMC Ambulatory Center, 3rd Floor | Buffalo | New York | United States | 14215 |
Sponsors and Collaborators
- University at Buffalo
- Kaleida Health
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 514091