Effect of Liraglutide on Clock Genes (LIR-CG)
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|ClinicalTrials.gov Identifier: NCT02783196|
Recruitment Status : Unknown
Verified May 2016 by Daniela Jakubowicz, Tel Aviv University.
Recruitment status was: Not yet recruiting
First Posted : May 26, 2016
Last Update Posted : May 26, 2016
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:
- 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).
- 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
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Liraglutide Drug: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Advantages of Liraglutide Mediated Through Its Effect on Clock Gene mRNA Expression|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
Experimental: Liraglutide (LIR)
Type 2 diabetic randomized to start with two 40 days treatment periods starting with Liraglutide ( IR) treatment, and then after 2 weeks of wash-out, will crossover to second treatment period of 40 days with placebo (PLA)
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.
Other Name: LIR
Placebo Comparator: Placebo (PLA)
Type 2 diabetic randomized to start with two 40 days treatment periods starting with placebo ( PLA) treatment, and then after 2 weeks of wash-out, will crossover to second treatment period of 40 days with Liraglutide ( LIR)
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.
Other Name: PLA
- Clock Gene expression [ Time Frame: Up to 95 days ]The Clock Genes mRNA expression will be assessed in white blood cells
- AMPK mRNA expression [ Time Frame: Up to 95 days ]he AMPK mRNA expression will be assessed in white blood cells on day 0, on day 40 and on day 95
- SIRT1 mRNA expression [ Time Frame: Up to 95 days ]SIRT1 mRNA expression will be assessed in white blood cells on day 0, on day 40 and on day 95
- Beta-cell function [ Time Frame: Up to 92 days ]Beta-cell function based on oral glucose tolerance test (OGTT) will be assessed on day -3, on day 37 and on day 92
- Overall glycemia [ Time Frame: Up to 95 days ]Overall glycemia assessed with continuous glucose monitoring system (CGMS) will be performed during 3 days at baseline from day - 3 to day 0, again from day 37 to 40 and three days before the end of intervention from day 92 to day 95
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): NCT02783196
|Contact: Daniela Jakubowicz, MDfirstname.lastname@example.org|
|Contact: Julio Wainstein, MDemail@example.com|
|Diabetes Unit E. Wolfson Hospital|
|Holon, Tel Aviv, Israel, 58100|
|Principal Investigator:||Julio Wainstein, MD||Diabetes Unit Wolfson Medical center|