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Risk of Metabolic Adaptation After Weight Loss

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ClinicalTrials.gov Identifier: NCT05139420
Recruitment Status : Recruiting
First Posted : December 1, 2021
Last Update Posted : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
Lisa Morselli, MD PhD, Medical College of Wisconsin

Study Description
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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.

Condition or disease Intervention/treatment Phase
Weight Loss Obesity Other: phentermine-topiramate combined with lifestyle intervention Other: lifestyle intervention with meal replacement program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss
Actual Study Start Date : September 10, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: lifestyle intervention plus phentermine-topiramate
Participants will be enrolled in a weight loss program based on lifestyle changes and the use of phentermine-topiramate to aid with weight loss
 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.
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05139420


Contacts
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Contact: Lisa L Morselli, MD PhD 414-955-6710 lmorselli@mcw.edu
Contact: Roland James 414-955-4992 rjames@mcw.edu

Locations
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United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Roland James    414-955-4992    rjames@mcw.edu   
Principal Investigator: Lisa L Morselli, MD PhD         
Sub-Investigator: Srividya Kidambi, MD         
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Lisa L Morselli, MD PhD Medical College of Wisconsin
More Information
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Responsible Party: Lisa Morselli, MD PhD, Assistant professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT05139420    
Other Study ID Numbers: PRO00039217
First Posted: December 1, 2021    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa Morselli, MD PhD, Medical College of Wisconsin:
resting metabolic rate
metabolic adaptation
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Body Weight Changes
Topiramate
Phentermine
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
 Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action