Risk of Metabolic Adaptation After Weight Loss

Not Applicable

Suspended

• Conditions: Obesity; Weight Loss
• Interventions: Other: phentermine-topiramate combined with lifestyle intervention; Other: lifestyle intervention with meal replacement program

• Registration Number: NCT05139420
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

This study aims at identifying the neurohormonal biomarkers that characterize individuals at risk of greater metabolic adaptation to weight loss, a disproportionate decline in resting metabolic rate during and after weight loss.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-12-01
• Study Start: 2022-09-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2029-11
• Study Completion: 2029-11

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

BMI > or = 30 any ethnicity

Exclusion Criteria

weight > or = 400 lbs.

diabetes (type 2 or type 1)

hypertension

heart disease

kidney disease

liver disease

active cancer

post solid organ or bone marrow transplant

HIV/AIDS

pregnancy

breastfeeding

current smoker

current recreational drug use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lifestyle intervention plus phentermine-topiramate	phentermine-topiramate combined with lifestyle intervention	Participants will be enrolled in a weight loss program based on lifestyle changes and the use of phentermine-topiramate to aid with weight loss
lifestyle intervention	lifestyle intervention with meal replacement program	Participants will be enrolled in a weight loss program based on lifestyle changes. They will be given a 6-month subscription to a calorie-reduced meal replacement program that also offers lifestyle coaching.

Primary Outcome Measures

Name	Time	Method
change in measured and predicted resting metabolic rate during and after weight loss	18 months	resting metabolic rate will be measured by indirect calorimetry every 2 months for 6 months, then every 6 months for an additional 12 month. Predicted resting metabolic rate will be calculated with a mathematical formula at the same time points

Secondary Outcome Measures

Name	Time	Method
change in circulating thyroid hormones during and after weight loss	18 months	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
change in circulating AgRP during and after weight loss	18 months	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
change in heart rate variability during and after weight loss	18 months	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
change in circulating PYY during and after weight loss	18 months	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
change in circulating leptin during and after weight loss	18 months	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
change in circulating GLP-1 during and after weight loss	18 months	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
change in 24h urine catecholamines during and after weight loss	18 months	urine will be assayed for these hormones every 2 months for 6 months, then every 6 months for an additional 12 months

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States