The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects



Status:Active, not recruiting
Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:20 - 80
Updated:11/8/2017
Start Date:May 23, 2014
End Date:May 2018

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The Effect of TRADJENTA ® (LINAGLIPTIN) on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects

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.


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
We found this trial at
1
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Buffalo, New York 14215
Phone: 716-898-1940
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