Effect of Liraglutide on Clock Genes

What Was Tested

This registered not phased trial tested Liraglutide.

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).

It had two arms (groups): Liraglutide (LIR) (experimental) and Placebo (PLA) (placebo comparator).

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).

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).

The registry classes the interventions as drug.

More on the Plan

Background: Cumulative evidence strongly implicates that the disruption of clock genes (CGs) plays a causative role in insulin resistance, hyperglycemia and β-cell dysfunction in type 2 diabetes (T2D).

CGs are synchronized by meal timing.

Objectives: 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).

Who Took Part

The registry lists 14 planned participants were the target.

It was open to people of any sex aged from 30 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with T2D diagnosed that were diagnosed \< 20 years. BMI: 26-32 kg/m2. Men and women. Between the ages of 30 and 75 years. Concomitant medication i.e. antihypertensive, anti-lipidemic, anti-thrombotic drugs will be allowed.

The full record lists 10 inclusion and 17 exclusion criteria; among the exclusions: type 1 diabetes or secondary forms of diabetes; use of glucose-lowering therapy apart from metformin and sglt2 inhibitors; treatment with glp-1 receptor agonists, dipeptidyl peptidase-4 (dpp-4) inhibitors within the last 3 months.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2016-07 with completion listed for 2016-12.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Clock Gene expression (time frame: Up to 95 days).

It also tracked 4 secondary outcomes, for example AMPK mRNA expression, SIRT1 mRNA expression, Beta-cell function and Overall glycemia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 14 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.