The TEMPO (Tracing the Effect of the MC4 Pathway in Obesity) Registry
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|ClinicalTrials.gov Identifier: NCT03479437|
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : May 4, 2021
|Condition or disease|
|Genetic Forms of Extreme Obesity|
Potential patients will be referred to coordinating centers by their healthcare provider (treating physician, diagnosing physician or primary care physician) and if eligible will be invited to enroll in the registry. The Registry Coordinating Center will be responsible for obtaining consent from adult patients and caregivers of minor patients (as well as assent from minors when appropriate), screening patients and enrolling them in the registry.
The registry will capture data entered by the patient, the patient's healthcare provider, and the patient's caregiver using online (electronic) survey tools administered at baseline, and annually thereafter. The patient's healthcare provider will complete the baseline Healthcare Provider survey tool, reporting the patient's baseline demographics, medical history, clinical information, and disease characteristics. The patient and caregiver will complete their dedicated baseline survey tools answering questions on the impact of disease on their everyday life. Survey tools include questions on patient and caregiver demographics, patient physical activity, patient food and hunger episodes, patient quality of life, and caregiver's perspective of disease burden on the family. Registry patients, caregivers, and healthcare providers will be contacted annually (approximately every 12 months) by the Registry Coordinating Center to complete an online follow-up survey tool including a smaller subset of questions from the baseline survey tools.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||303 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||The TEMPO (Tracing the Effect of the MC4 Pathway in Obesity) Registry Involving Variants in Hypothalamic Genes Upstream or Downstream From the Melanocortin-4 Receptor (MC4R)|
|Actual Study Start Date :||April 15, 2018|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||December 1, 2020|
- Assessment of Quality of Life [ Time Frame: 5 years ]Evaluate the quality of life through annual patient and caregiver reported surveys.
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): NCT03479437
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|University of Alberta|
|Edmonton, Canada, T6G 2B7|
|Principal Investigator:||Ihuoma Eneli||Nationwide Children's Hospital|
|Study Chair:||Liz Stoner||Rhythm Pharmaceuticals, Inc.|