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In a previous study (NCT04081337), 55 participants with obesity participated on a 18-week lifestyle intervention to reduce their body weight, targeting 10% body weight loss. The participants received tirzepatide (15mg after titration) or placebo during the weight loss intervention. Before and after the lifestyle intervention, energy expenditure (48-h room indirect calorimetry) and body weight and composition (dual-X-ray absorptiometry) were measured, thus enabling the assessment of metabolic adaptation. In this study, participants having provided their consent to be re-contacted will be invited to attend the research center 12,18 and 24 months after completing the lifestyle intervention. Body weight and composition will be measured, aiming to explore the association between metabolic adaptation and changes in body weight and composition after a weight loss intervention. In addition, we will explore whether weight and fat mass changes are different between groups, and whether these effects are mediated by metabolic adaptation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo |
| ||
| Tirzepatide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive lifestyle change therapy | Behavioral | Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | 12 months | |
| Body weight | 18 months | |
| Body fat mass (DXA) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants having completed the NCT04081337 study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70809 | United States |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D015430 | Weight Gain |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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| Tirzepatide | Drug | Participant of both groups will be followed for 24 months after completing the parent trial intervention, with no intervention during the follow-up |
|
| 12 months |
| Body fat mass (DXA) | 18 months |
| Body fat mass (DXA) | 24 months |
| Body fat free mass (DXA) | 12 months |
| Body fat free mass (DXA) | 18 months |
| Body fat free mass (DXA) | 24 months |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |