Risk of Metabolic Adaptation After Weight Loss

Obesity Clinical Trial

Official title:

Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05139420
• Other study ID #: PRO00039217
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2022
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Medical College of Wisconsin
• Contact: Lisa L Morselli, MD PhD
• Phone: 414-955-6710
• Email: lmorselli[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

Other:
• phentermine-topiramate combined with lifestyle intervention
participants will be enrolled in a medical weight loss program and will be offered a 6 month prescription for phentermine-topiramate (note: The goal of the study is NOT to assess efficacy or safety of this drug) in addition to lifestyle advice.
• lifestyle intervention with meal replacement program
participants will be enrolled in a medical weight loss program and will be given a 6 month subscription to a calorie-reduced meal replacement program, in addition to lifestyle advice.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in measured and predicted resting metabolic rate during and after weight loss	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	18 months
Secondary	change in circulating leptin during and after weight loss	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months	18 months
Secondary	change in circulating thyroid hormones during and after weight loss	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months	18 months
Secondary	change in circulating GLP-1 during and after weight loss	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months	18 months
Secondary	change in circulating PYY during and after weight loss	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months	18 months
Secondary	change in circulating AgRP during and after weight loss	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months	18 months
Secondary	change in 24h urine catecholamines during and after weight loss	urine will be assayed for these hormones every 2 months for 6 months, then every 6 months for an additional 12 months	18 months
Secondary	change in heart rate variability during and after weight loss	blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months	18 months