Back to resultsRisk of Metabolic Adaptation After Weight Loss
Primary Purpose
Weight Loss, Obesity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
phentermine-topiramate combined with lifestyle intervention
lifestyle intervention with meal replacement program
Sponsored by
About this trial
This is an interventional other trial for Weight Loss focused on measuring resting metabolic rate, metabolic adaptation
Eligibility 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
Sites / Locations
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
lifestyle intervention plus phentermine-topiramate
lifestyle intervention
Arm Description
Participants will be enrolled in a weight loss program based on lifestyle changes and the use of phentermine-topiramate to aid with weight loss
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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
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
Full Information
NCT ID
NCT05139420
First Posted
November 18, 2021
Last Updated
May 10, 2023
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT05139420
Brief Title
Risk of Metabolic Adaptation After Weight Loss
Official Title
Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 10, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Obesity
Keywords
resting metabolic rate, metabolic adaptation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lifestyle intervention plus phentermine-topiramate
Arm Type
Experimental
Arm Description
Participants will be enrolled in a weight loss program based on lifestyle changes and the use of phentermine-topiramate to aid with weight loss
Arm Title
lifestyle intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
phentermine-topiramate combined with lifestyle intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
lifestyle intervention with meal replacement program
Intervention Description
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 Outcome Measure Information:
Title
change in measured and predicted resting metabolic rate during and after weight loss
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
change in circulating leptin during and after weight loss
Description
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Time Frame
18 months
Title
change in circulating thyroid hormones during and after weight loss
Description
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Time Frame
18 months
Title
change in circulating GLP-1 during and after weight loss
Description
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Time Frame
18 months
Title
change in circulating PYY during and after weight loss
Description
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Time Frame
18 months
Title
change in circulating AgRP during and after weight loss
Description
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Time Frame
18 months
Title
change in 24h urine catecholamines during and after weight loss
Description
urine will be assayed for these hormones every 2 months for 6 months, then every 6 months for an additional 12 months
Time Frame
18 months
Title
change in heart rate variability during and after weight loss
Description
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa L Morselli, MD PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Risk of Metabolic Adaptation After Weight Loss
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