NCT03962699Active, not recruiting
Impact of Weight Loss on the Human Sperm Epitranscriptome
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
Increasing evidence suggests that non-communicable diseases such as in particular obesity and its associated metabolic diseases are inherited from parents to children throughout several generations by epigenetic mechanisms. Thus, this environmental stress would induce epigenetic modification in the germ line that once transmitted and maintained in the progeny would induce the development of the parental pathologies. Considering the increasing prevalence of these pathologies worldwide, we urgently need to understand this process in human. Based on published and unpublished data demonstrating that sperm RNAs are vectors of epigenetic inheritance of obesity mouse model, the investigative team hypothesizes that epitranscriptome of obese men play a central role in the paternal epigenetic inheritance of obesity and its associated metabolic diseases as epigenetic vectors in this process. To validate this hypothesis, the investigative team will use sperm from non-obese and obese men taken before and after surgery weight loss. Thanks to these cohorts, they propose to: (i) compare the epitranscriptome profiles of non-obese and obese men to identify the RNAs molecules which will be either qualitatively or quantitatively epigenetically modulated by obesity; (ii) compare the epitranscriptome profiles of obese men before and after surgery-weight loss to assess the reversibility of the newly acquired RNA modifications. Giving some answers to this central question will provide not only some clues about the molecular mechanisms involved in this process, elements which might be crucial to stop the spread of this disorder, but will also allow the identification of obese-susceptibility loci which expression may be modulate by environmental factors and consequently able to transmit the disease.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 45 (estimated)
- First submitted
- 22 May 2019
- Start date
- 20 Jul 2019
- Primary completion date
- 19 Dec 2025
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Diseases
- Obesity
- NCT number
- NCT03962699
What you commit to
- Study type: Observational
- Planned participants: 45
- From 20 Jul 2019 to the primary completion date, 19 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- exhibiting a normal BMI from 18 to 25
- aged between 20-50 years
- selected as fertile men in the context of a a medical consultation in Reproduction Biology laboratories
- does not show their opposition to participate in the research study
- presented no difficulties in oral and written comprehension of french language.
Age in the registry: 20 years to 50 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Archet Coordinator of this site? Confirm its status | Nice | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.