Obesity Treatment to Improve Diabetes

What Was Tested

The trial (not phased) is built around Semaglutide and Liraglutide.

It had five arms (groups): GLP1RA alone (experimental), SGLT2i alone (experimental), GLP1RA/SGLT2i combination (experimental), GLP1RA/SGLT2i combination with intensive lifestyle changes (experimental) and Usual Care (experimental).

The registry classes the interventions as drug and other.

More on the Plan

Several complimentary pathological phenomena are postulated to have a mechanistic role in the causal association between obesity, T1D/T2D, and CKD.

Excess adiposity precipitate multiple stimuli, including metabolic, hypertensive, and local mechanical stress, which combine to elicit pathogenic responses causing CKD.

Changes in volume, structure, and function of adipose tissue contribute to kidney injury through multiple mechanisms.

Attendant glucotoxicity can provoke mesangial and tubular cell stress in the kidney through excess glycolysis-driven oxidative stress and the accumulation of advanced glycation end-products.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

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

Examples of who could join: Be aged between 21-65 years,. Have a BMI ≥ 25 kg/m2,. Have established diagnosis of Chronic Kidney Disease stage 1-4. Able to give informed consent.

The full record lists 6 inclusion and 26 exclusion criteria; among the exclusions: have been treated with glp-1 or sglt2i within the last 3 months and/or have a history of glp1ra or sglt2i intolerance; treatment with anti-obesity drugs within 12 weeks prior to randomisation; experienced diabetic ketoacidosis within 6 months of screening visit.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2023-04-01 with completion listed for 2024-01-01.

It ran at 1 site in Kuwait.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Weight (time frame: 26 weeks).

It also tracked 6 secondary outcomes, for example Glycaemia, Hypertension, Lipidaemia, Albuminuria, Waist circumference and Weight change.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide and Liraglutide in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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