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Risk of Metabolic Adaptation After Weight Loss

Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05139420
Enrollment
60
Registered
2021-12-01
Start date
2022-09-10
Completion date
2031-11-01
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Weight Loss

Keywords

resting metabolic rate, metabolic adaptation

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.

Interventions

OTHERlifestyle 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.

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in measured and predicted resting metabolic rate during and after weight loss18 monthsresting 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

MeasureTime frameDescription
change in circulating leptin during and after weight loss18 monthsblood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
change in circulating thyroid hormones during and after weight loss18 monthsblood 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 loss18 monthsblood 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 loss18 monthsblood 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 loss18 monthsblood 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 loss18 monthsurine will be assayed for these hormones every 2 months for 6 months, then every 6 months for an additional 12 months
change in heart rate variability during and after weight loss18 monthsblood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLisa L Morselli, MD PhD

Medical College of Wisconsin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026