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OpenTrials
Active, Not Recruiting

NCT Number: NCT05139420

Risk of Metabolic Adaptation After 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Weight Loss Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle intervention with meal replacement program

Other

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.

Primary outcomes

  1. change in measured and predicted resting metabolic rate during and after weight loss

    Time frame: 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 outcomes

  1. change in circulating leptin during and after weight loss

    Time frame: 18 months

    blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months

  2. change in circulating thyroid hormones during and after weight loss

    Time frame: 18 months

    blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months

  3. change in circulating GLP-1 during and after weight loss

    Time frame: 18 months

    blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months

  4. change in circulating PYY during and after weight loss

    Time frame: 18 months

    blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months

  5. change in circulating AgRP during and after weight loss

    Time frame: 18 months

    blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months

  6. change in 24h urine catecholamines during and after weight loss

    Time frame: 18 months

    urine will be assayed for these hormones every 2 months for 6 months, then every 6 months for an additional 12 months

  7. change in heart rate variability during and after weight loss

    Time frame: 18 months

    blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss

Important dates

Study start
2022
Primary completion
2031
Study completion
2031
First posted
Dec 1, 2021
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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