Risk of Metabolic Adaptation After Weight Loss

Study Overview
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Brief Summary
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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.

Official Title
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Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss

Conditions
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Weight Loss, Obesity

Intervention / Treatment
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* Other: phentermine-topiramate combined with lifestyle intervention
* Other: lifestyle intervention with meal replacement program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lifestyle intervention plus phentermine-topiramate<br>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<br>* 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.<br>|
| Experimental: lifestyle intervention<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resting metabolic rate, metabolic adaptation