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Effect of Liraglutide on Clock Genes

NCT02783196 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-05-26

No results posted yet for this study

Summary

This study is undertaken to search whether glucagon-like peptide-1 (GLP-1) analogue, Liraglutide, by enhancing clock gene and AMPK-SIRT-1 mRNA expression, may reverse the metabolic abnormalities of type 2 diabetes, improving overall glycemic excursion, inflammatory cytokines and β-cell function in type 2 diabetes individuals.

The investigators aim is to compare the effect of 40 days treatment with Liraglutide (LIR) vs. 40 days with placebo (PLA) in T2D participants on the following end points:

Primary end-points:

* Change in the oscillation of CG (i.e. CLOCK, BMAL1, Per1, Per2, Cry1, Cry2, Rev-erb-alpha Ror-alpha), AMPK, SIRT1 and inflammatory cytokines mRNA expression in white blood cells (WBCs).

Secondary end-points:

* Overall daily glycemic variation assessed with continuous glucose monitoring system (CBMS)
* Serum levels of inflammatory cytokines (TNF-α, IL-1β, IL-6)
* β-Cell function derived from glucose and insulin response to OGTT

Conditions

Interventions

DRUG

Liraglutide

In the LIR arm, the participants will be provided with instructions in using pre-filled single-use plastic syringes ready for once daily subcutaneous injection of LIR. From day 1 to day 10, with LIR daily dose of 0.6 mg (0.1 ml), followed by other 10 day courses (from day 11 to day 20) with LIR 1.2 mg (0.2 ml), then will be up-titrated to high dose 1.8 mg (0.3 ml) of LIR (from day 21 to day 40). At crossover-day 40, the participants will undergo a 14 days wash-out period, day 41 to day 55.

DRUG

Placebo

In the PLA arm, the participants will be provided with instructions in using pre-filled single-use plastic syringes ready for once daily subcutaneous injection of PLA. Will start with PLA with matched volume saline injections of 0.1 ml PLA during the first 10 days, followed by 10 days, with 0.2 ml PLA, thereafter PLA will be up-titrated to highest volume 0.3 ml placebo for the rest of the PLA treatment period . At crossover-day 40, the participants will undergo a 14 days wash-out period, day 41 to day 55.

Sponsors & Collaborators

  • Tel Aviv University

    lead OTHER

Principal Investigators

  • Julio Wainstein, MD · Diabetes Unit Wolfson Medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2016-12-31
Completion
2017-06-30

Countries

  • Israel

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02783196 on ClinicalTrials.gov