Improving Beta Cell Function in Mexican American Women With Prediabetes

What Was Tested

The trial (phase 4) is built around Liraglutide.

The Investigators have chosen to focus on MA women because MA women are at very high risk for progression to diabetes and have not traditionally been involved in weight management studies since they are thought to be difficult to recruit and retain in such programs.

However, investigators have had particular success in working with young MA women using specifically developed ethnic and gender conscious programs.

It had two arms (groups): Diet-induced weight loss (active comparator) and Weight loss plus liraglutide (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

The primary endpoint will be β-cell function (AIRg) in response to lifestyle change with and without GLP-1 agonist at 3 months.

Secondary endpoints will be reversal of metabolic syndrome and changes in plasma biomarkers.

By the end of 3 months, the prediabetic subject will be in the best possible metabolic control, and investigators would predict that the liraglutide group would reveal better β-cell function.

The program will be continued for 3 more months for transition to regular healthy meals with the goal of weight maintenance.

Who Took Part

360 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Willingness to complete protocol. English or Spanish literate.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: 30 min or more of moderate to vigorous activity more than 3 times per week; cardiovascular disease; physical limitations that might be aggravated by moderate physical activity.

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 Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

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

It started in 2016-05 with completion listed for 2019-03.

It ran at 4 sites in United States (4).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Beta Cell Function (time frame: 3 months).

It also tracked 7 secondary outcomes, for example Waist Circumference, Fasting Glucose, Triglycerides, HDL cholesterol, Blood Pressure and Heart Sensitive C-reactive protein.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 360 people.

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

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