Combined Effects of GLP-1 Analogue and Exercise on Maintenance of Weight Loss and Health After Very-low Calorie Diet

What Was Tested

The trial (phase 4) is built around Liraglutide for fat loss, obesity & body recomposition.

Introduction: The success rate of weight loss maintenance is limited.

Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after diet-induced weight loss followed by one-year treatment with a glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise, or the combination of both treatments as compared with placebo in individuals with obesity.

Methods and analysis: This is an investigator-initiated, randomized, placebo-controlled, parallel group trial.

It had four arms (groups): Liraglutide + exercise (active comparator), Liraglutide + non-exercise (other), Placebo + exercise (other) and Placebo + non-exercise (no intervention).

The registry classes the interventions as behavioral and drug.

More on the Plan

Glucagon-like peptide-1 (GLP-1) is an incretin hormone primarily secreted from enteroendocrine L-cells in the gut after food intake.

Physically active individuals have lower inflammatory biomarker concentrations than their inactive counterparts \[24\], possibly explained by antiinflammatory effects of an acute bout of exercise \[40\] and lower levels of visceral adipose tissue \[41\].

GLP-1 has also emerged as an immunomodulatory agent \[42,43\].

Objective: The objectives of this study are to investigate the maintenance of weight loss and immunometabolic health outcomes over 52 weeks with liraglutide treatment, physical exercise, and the combination in individuals with obesity, after a very low-calorie diet.

Who Took Part

The registry lists 215 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: BMI \> 32 and \< 43 (kg/m2). Age \>18 and \<65 years.

The full record lists 3 inclusion and 17 exclusion criteria; among the exclusions: angina pectoris, coronary heart disease, congestive heart failure (nyha iii-iv); severe hepatic impairment; inflammatory bowel disease.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Liraglutide.

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

It started in 2016-09 with completion listed for 2019-11.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Body weight change (kg) (time frame: Change from baseline to end-of-treatment (52 weeks)).

It also tracked 10 secondary outcomes, for example Body composition (fat percentage), Body composition (fat mass and fat free mass), Waist and hip circumference, HOMA-IR, Matsuda Index and Hormonal regulation of blood glucose.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 215 people with fat loss, obesity & body recomposition.

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

More context: the Liraglutide compound page, Fat loss, obesity & body recomposition research.