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Official title NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
ClinicalTrials.gov ID: NCT04942093
What this study is testing
- What it's testing
- Obesity is a major public health problem and is constantly on the rise. Therapeutic approaches based on dietary advice, physical activity and the management of psychological difficulties are not always sufficient to achieve a lasting weight reduction.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patient eligible for bariatric surgery (according to HAS criteria) whose sleeve gastrectomy is scheduled
- Patient with morbid obesity (BMI ≥ 40)
- Age ≥ 18 years and ≤ 65 years
- Haemoglobinemia ≥ 12 g/dL in men and ≥ 11 g/dL in women
- Patient speaking and understanding French
You likely can't join if
- Contraindication to bariatric surgery detected during the preoperative assessment
- Medical contraindication to a restrictive diet
- Type I or II insulin-requiring diabetes
- Severe renal insufficiency defined by a blood filtration rate \< 30 mL/min
- Person wearing a pacemaker or any other implant with the same functions (cochlear implant, bladder battery, etc.)
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship
See the full eligibility criteria
- Patient eligible for bariatric surgery (according to HAS criteria) whose sleeve gastrectomy is scheduled
- Patient with morbid obesity (BMI ≥ 40)
- Age ≥ 18 years and ≤ 65 years
- Haemoglobinemia ≥ 12 g/dL in men and ≥ 11 g/dL in women
- Patient speaking and understanding French
- Adult having read and understood the information letter and signed the consent form
- Woman of childbearing age with effective / very effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) prior to surgery and a negative -HCG blood pregnancy test at inclusion...
- Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhoea for at least 12 months prior to the inclusion visit)
- Patient affiliated with, or beneficiary of a social security (health insurance) category
- Contraindication to bariatric surgery detected during the preoperative assessment
- Medical contraindication to a restrictive diet
- Type I or II insulin-requiring diabetes
- Severe renal insufficiency defined by a blood filtration rate \< 30 mL/min
- Person wearing a pacemaker or any other implant with the same functions (cochlear implant, bladder battery, etc.)
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship
- A history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent him/her from giving informed...
The study team makes the final eligibility decision.
Where it's taking place
- Dieppe, France
- Le Havre, France
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dieppe, France; Le Havre, France; Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.