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The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects (1971)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372630
Recruitment Status : Unknown
Verified November 2017 by Paresh Dandona, University at Buffalo.
Recruitment status was:  Active, not recruiting
First Posted : February 26, 2015
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Kaleida Health
Information provided by (Responsible Party):
Paresh Dandona, University at Buffalo

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
Type 2 Diabetes Drug: Linagliptin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of TRADJENTA ® (LINAGLIPTIN) on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects
Actual Study Start Date : May 23, 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

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 Name: TRADJENTA




Primary Outcome Measures :
  1. change in JNK-1 protein in MNC before and after linagliptin use as compared to placebo. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. change in inflammatory mediators in serum and adipose tissue following 12 weeks of treatments compared to placebo. [ Time Frame: 12 weeks ]
  2. change in inflammation and oxidative stress following a single does of linagliptin. [ Time Frame: 12 Weeks ]
  3. change in insulin sensitivity following linagliptin treatment compared to placebo. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372630


Locations
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United States, New York
ECMC Ambulatory Center, 3rd Floor
Buffalo, New York, United States, 14215
Sponsors and Collaborators
University at Buffalo
Kaleida Health

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Responsible Party: Paresh Dandona, Principal Investigator, University at Buffalo
ClinicalTrials.gov Identifier: NCT02372630    
Other Study ID Numbers: 514091
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Hyperinsulinism
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action