Risk of Metabolic Adaptation After Weight Loss

Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Other: lifestyle intervention with meal replacement program

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lifestyle intervention; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Lisa L Morselli, MD PhD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): November 1, 2031

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: resting metabolic rate; metabolic adaptation
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Weight Loss; Hypoglycemic Agents; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anticonvulsants; Appetite Depressants; Anti-Obesity Agents; Central Nervous System Stimulants; Sympathomimetics; Topiramate; Phentermine
• Other Study ID Numbers: PRO00039217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No