NCT03479437

The TEMPO (Tracing the Effect of the MC4 Pathway in Obesity) Registry

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 303 (actual)
• Sponsor: Rhythm Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

A voluntary prospective study that will allow registration and follow-up of individuals with MC4R pathway genetic obesity.

Detailed description

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.

Conditions

• Genetic Forms of Extreme Obesity

Timeline

• Start date: 2018-04-15
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2018-03-27
• Last updated: 2021-05-04

Locations

2 sites across 2 countries: United States, Canada