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Trial record 16 of 396 for:    LIRAGLUTIDE

Effects of Liraglutide on ER Stress in Obese Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02344186
Recruitment Status : Unknown
Verified January 2016 by Temple University.
Recruitment status was:  Active, not recruiting
First Posted : January 22, 2015
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Temple University

Brief Summary:

The main objective of the study will be to test the hypothesis that treatment with Liraglutide will decrease ER stress and adipose tissue in obese patients with type 2 diabetes. Experimental Approach: The investigators will use a prospective, single blind, placebo controlled study design to study 12 obese patients with type 2 diabetes mellitus (T2DM). 6 patients will first receive Liraglutide for 24 weeks followed by placebo for 12 weeks. The other 6 patients will first receive placebo for 12 weeks followed by Liraglutide for 24 weeks.

Measurements: The investigators will determine glycemic control (with HbA1c), body composition (bioelectric impedance analysis), insulin sensitivity (with hyperinsulinemic-euglycemic clamps), insulin secretion (with oral glucose tolerance testing), energy balance (calories in vs. calories out), plasma lipid levels and obtain subcutaneous fat biopsies to determine ER stress response markers before and after placebo and before and after Liraglutide treatment.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Liraglutide Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Effects of Liraglutide on Endoplasmic (ER) Stress in Obese Patients With Type 2 Diabetes
Study Start Date : May 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide
Liraglutide will be started first with 0.6 mg/d for 1 week, then increased to 1.2 mg/d from week 2 to week 12, followed by 1.8 mg/d from week 12 to week 24.
Drug: Liraglutide
Crossover design - 24 weeks on active drug and 12 weeks daily placebo
Other Name: Victoza

Placebo Comparator: Placebo
Subjects will receive placebo for 12 weeks.
Drug: Liraglutide
Crossover design - 24 weeks on active drug and 12 weeks daily placebo
Other Name: Victoza




Primary Outcome Measures :
  1. Changes in unfolded protein response markers [ Time Frame: baseline, 6 months, 9 months ]
    Changes in unfolded protein response markers in adipose tissue biopsy samples. Specifically, the investiagors will determine changes in mRNA (by RT-PCR) and protein (by Western blots) levels of the following ER stress markers: GRP78, ATF4, XBP-1s, PDI 3B, calreticulin and calnexin.


Secondary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: baseline, 3 months, 6 months and 9 months ]
    Changes in insulin resistance will be determined by measuring changes in total body glucose uptake and in plasma free fatty acid (FFA) levels during euglycemic-hyperinsulinemic clamping.

  2. Glucose control [ Time Frame: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months ]
    Glucose control will be assessed by monthly A1c determinations.

  3. Energy expenditure [ Time Frame: baseline, 3 months, 6 months, 9 months ]
    Changes in energy expenditure will be assessed by indirect calorimetry

  4. Body weight [ Time Frame: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months ]
    Patients will be weighed monthly

  5. Body composition [ Time Frame: baseline, 3 months, 6 months and 9 months ]
    Body composition will be determined using bioelectrical impendance.

  6. Beta cell function [ Time Frame: baseline, 6 months, 9 months ]
    Subjects will undergo an oral glucose tolerance tests(OGTT) to assess beta cell function.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with established type 2 diabetes, BMI 27-35, Age - 18-75 years, HbA1c 7-10%, patients treated with exercise, diet, metformin and/or alpha glucosidase inhibitors (all up to ½ of their maximal dose) or pioglitazone (up to 30 mg/d), ability to provide informed consent before any trial-related activities.

Exclusion Criteria:

  • Patients with pancreatitis or a history of pancreatitis, patients with HbA1c < 7% or > 10%, type 2 diabetic patients treated with insulin, sulfonylureas, meglitinides, DPP4 inhibitors, GLP1 agonists or corticosteroids, patients with hypoglycemia unawareness and with impaired liver functions (≥ 2.5 times the upper normal limit), known or suspected allergy against liraglutide or contraindications to liraglutide (as specified in the product prescribing information), pregnancies, breastfeeding or intention of becoming pregnant or not using adequate contraceptive measures, patients with a personal or family history of medullary thyroid cancer and patients with Multiple Endocrine Neoplasia type 2.

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): NCT02344186


Locations
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United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02344186     History of Changes
Other Study ID Numbers: 21440
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016
Keywords provided by Temple University:
diabetes, endoplasmic reticulum stress, obesity, GLP1 analogs
Additional relevant MeSH terms:
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Liraglutide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists