Risk of Metabolic Adaptation After Weight Loss

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05139420
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss; Obesity	Other: phentermine-topiramate combined with lifestyle intervention	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• 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
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 prescribed phentermine-topiramate to help with weight loss. The goal of the study is NOT to assess efficacy or safety of this drug

Outcome Measures

Primary Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Medical College of Wisconsin

Investigators

• Principal Investigator: Lisa L Morselli, MD PhD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lisa Morselli, MD PhD, Assistant professor, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT05139420
• Other Study ID Numbers: PRO00039217
• First Posted: Dec 1, 2021
• Last Update Posted: Apr 5, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Assistant professor, Medical College of Wisconsin: resting metabolic rate; metabolic adaptation
• Additional relevant MeSH terms: Body Weight; Weight Loss; Topiramate; Phentermine

Study Results

No Results Posted as of Apr 5, 2022