Health TrialsbyHealthPanel

Weight Changes After Incretin-mimetics

ConditionObesity and Obesity-related Medical Conditions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMedical College of Wisconsin

About this trial

The goal of this study is to identify people at risk of weight regain after stopping an injectable weight loss drug. The main question the investigators aim to answer is: Can weight regain be predicted by measuring circulating Agouti-related peptide, a small protein coming from the brain?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adults 18 years or older

men and women

prescribed an incretin-mimetic for weight loss and for whom insurance coverage for this specific drug will lapse

any ethnicity

Disqualifiers

weight > or = 400 lb

type 1 or type 2 diabetes

patients taking steroid medications

anemia

Trial design

Design model

Single group

Treatments tested in this trial

  • discontinuation of weight loss medication

    Other intervention

    Participants will be studied right before their injectable weight loss medication runs out, and 3 months later

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: incretin mimetic discontinuationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

weight change

weight trajectories in the 3 months after treatment discontinuation

Time frame
3 months
2

fasting and post-prandial circulating AgRP

Circulating AgRP will be measured after an overnight fast and during a 3-hour mixed meal test, at baseline (while still on injectable weight loss drug) and 3 months later. The mixed meal will consist in a nutrtional shake consumed in 5 min.

Time frame
3 months

Secondary outcomes

1

subjective hunger ratings

Participants will be asked to rate current hunger with a visual analogue scale in fasting conditions and hourly during a 3-hour mixed meal test. This will be done at baseline (while still on injectable weight loss drug) and 3 months after treatment discontinuation. Scores go from 0 to 100, with 0 indicating "Not hungry at all" and 100 indicating "Extremely hungry".

Time frame
3 months
2

resting metabolic rate (RMR)

RMR will be measured in fasting conditions at baseline (while still on injectable weight loss drug) and 3 months after treatment discontinuation.

Time frame
3 months
3

RMR adaptation

RMR adaptation will be estimated baseline (while still on injectable weight loss drug) and 3 months after treatment discontinuation. RMR adaptation will be defined as the difference between measured and predicted RMR. Predicted RMR will be computed with a linear regression equation obtained from baseline data from the whole cohort.

Time frame
3 months
4

body composition

Body composition (fat mass, fat-free mass) will be measured at baseline and 3 months later by DXA

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

University of Wisconsin, Milwaukee

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: