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

Type 2 Diabetes Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372630
• Other study ID #: 514091
• Status: Completed
• Phase: Phase 4
• Start date: May 23, 2014
• Est. completion date: May 1, 2018

Study information

• Verified date: January 2023
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. The study enrolls type 2 patients with diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

Age 20-80 years inclusive. Type 2 diabetes BMI =30 kg/m2 Subjects on statins, ACE inhibitors, thiazolidinediones 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Inflammation
• Insulin Resistance
• Type 2 Diabetes

Intervention

Drug:
• Linagliptin
5 mg daily oral tablets of linagliptin
• Placebo
matching placebo giving orally daily

Locations

Country	Name	City	State
United States	ECMC Ambulatory Center, 3rd Floor	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Kaleida Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	JNK-1 Protein in MNC	JNK-1 protein in MNC before and after linagliptin use as compared to placebo.	Week 0, Week 2, Week 4, Week 12
Secondary	IL-1ß mRNA Levels	Comparing IL-1B between Linagliptin group and placebo group based on the PCR test, between week 0 and week 12.	Week 0, Week 2, Week 4, Week 12
Secondary	Oxidative Stress (as ROS Generation Level)	oxidative stress (ROS generation level) following linagliptin. ROS generation measurement by chemiluminescence of PMN cells	Week 0, Week 2, Week 4, Week 12
Secondary	Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp	Insulin sensitivity is measured with HE clamp. Glucose Infusion Rate was titrated to maintain blood glucose concentration at the fasting glucose level. Plasma samples for glucose was obtained at 10-minute intervals starting 30 minutes before the clamp, to quantitate rates of whole-body glucose disposal. Difference from baseline at 12 weeks is calculated and compared to placebo arm	At baseline and week 12