NUTritional Impact of a Hypocaloric Hyperprotein Diet Before Obesity Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Poor diet tolerance
研究概览
简要总结
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.
Bariatric surgery (or obesity surgery), accompanied by therapeutic education and adequate medical and dietary monitoring, can lead to significant and lasting weight loss. It is indicated as a second-line treatment for patients who have failed medical treatment, whose BMI is greater than or equal to 40 or whose BMI is greater than or equal to 35 with comorbidities (type 2 diabetes, arterial hypertension, obstructive sleep apnoea-hypopnoea syndrome, severe joint disorders).
The surgeon may be very bothered by the intra-abdominal fat mass and especially by steatotic hepatomegaly (increase in the size of the liver and its fat load).
Faced with this problem, various preoperative strategies such as the placement of an intra gastric balloon have been tried to decrease the size of the liver but a systematic review from 2016 indicates that a low calorie diet is preferable. Preoperative weight loss can reduce fat load and liver volume very rapidly. This meta-analysis shows that all low-calorie, high-protein diets are effective and that the optimal duration (4 weeks), compliance and tolerance are important factors for success.
详细描述
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.
Bariatric surgery (or obesity surgery), accompanied by therapeutic education and adequate medical and dietary monitoring, can lead to significant and lasting weight loss. It is indicated as a second-line treatment for patients who have failed medical treatment, whose BMI is greater than or equal to 40 or whose BMI is greater than or equal to 35 with comorbidities (type 2 diabetes, arterial hypertension, obstructive sleep apnoea-hypopnoea syndrome, severe joint disorders).
The surgeon may be very bothered by the intra-abdominal fat mass and especially by steatotic hepatomegaly (increase in the size of the liver and its fat load).
Faced with this problem, various preoperative strategies such as the placement of an intra gastric balloon have been tried to decrease the size of the liver but a systematic review from 2016 indicates that a low calorie diet is preferable. Preoperative weight loss can reduce fat load and liver volume very rapidly. This meta-analysis shows that all low-calorie, high-protein diets are effective and that the optimal duration (4 weeks), compliance and tolerance are important factors for success.
However, there is no consensus on the benefit/risk balance of a preoperative diet and there is considerable variability in approach at national and international level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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, for the duration of the study
- •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
排除标准
- •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 consent
结局指标
主要结局
Poor diet tolerance
时间窗: 4 weeks after the beggining of the diet
At least one of the following biological abnormalities at the end of the diet period: * Lymphopenia acquired during the diet * Anemia (Hb\<11g/dL for men Hb\<10g/dL for women) or a decrease in hemoglobin of more than 2 g/dL * Onset or worsening of vitamin B1 deficiency from baseline (Vit B1 \< 78 nmol/L) OR At least one of the following clinical abnormalities: * Decrease in muscle strength (difference in muscle strength measured with a HandGrip at Visit 2 and Visit 3) greater than three standard deviations from the matched Visit 3 - visit 2 differences of the control group after removal of measurement bias on a log-transformed strength variable, associated with weight loss \> 5% in 1 month or a decrease in percent lean mass ≥ 1% relative to visit 2 * Any permanent discontinuation
次要结局
- Compliance(during the 4 weeks of the diet)
- Reduced muscle strength(4 weeks after the beggining of the diet)
- Comparison of the quality of life between "with diet" and "without diet" with "EQVOD" questionnaire(Baseline, 4 weeks after the beggining of the diet and 3 months postoperatively)
- Degree of exposure(one day from surgery)
- Weight loss(4 weeks after the beggining of the diet and 3 months postoperatively)
- Evolution of physical activity(Baseline, 4 weeks after the beggining of the diet and 3 months postoperatively)
- Length of hospital stay(Four months from surgery)
- Digestive tolerance(during the 4 weeks of the diet)
- Operating time(one day from surgery)
- Intraoperative and postoperative complications(Between surgery and 3 months postoperatively)