DRKS00031928已完成Unknown
Intermittent fasting for obesity in general practice - a controlled, randomized implementation study within the Research Network Baden-Wuerttemberg - INDUCT
niversitätsklinikum Tübingen, Institut für Allgemeinmedizin und Interprofessionelle Versorgung0 个研究点目标入组 151 人开始时间: 2023年6月22日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 151
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •BMI 30-45 kg/m2,
- •- Regular care through recruiting 'research practice PLUS'
- •- Capacity to consent
- •- No objection to data processing for the purpose of identifying potential study participants (case finding)
- •- Signed study-specific informed consent and consent to data processing
排除标准
- •- No regular primary care through 'research practice PLUS'
- •- Objection to data processing for the purpose of identifying potential study participants (case finding)
- •- No capacity to consent
- •Presence of any of the following:
- •o Pregnancy (up to 6 months post-partum) or lactation period.
- •o History for or presence of an eating disorder: anorexia, bulimia, binge eating disorder.
- •o Presence of uncontrolled hyper-/hypothyroidism, i.e. a TSH value outside the target range under hormone replacement or thyrostatic therapy, or newly diagnosed hypo-/hyperthyroidism in the past six months.
- •o Current presence of an organic or symptomatic mental disorder as assessed by the study physician.
- •o Diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin therapy
- •o Anamnestic evidence for:
- •> Cardiovascular event within the past 12 months (acute coronary syndrome, cardiac catheterization, bypass surgery, hospitalization due to heart
- •failure, stroke, transient ischemic attack) or uncontrolled arrhythmia, i.e. presence of a known brady/tachycardia or history of brady/tachycardia in the
- •past, if applicable, with persistent fail in rhythm/rate control, symptomatic AV block II° type Mobitz I, AV block II° (type Mobitz II)/III°.
- •> Active or therapeutically unstable (insufficiently achieved symptom control) or expected risk of worsening of the underlying disease under TRE in
- •diseases from the fields of rheumatology, oncology, hematology, infectiology, gastroenterology, psychiatry, nephrology or endocrinology.
- •> Uncontrolled arterial hypertension, i.e. blood pressure values outside the individual target range under therapy or initial diagnosis of arterial
- •hypertension in the course of the study.
- •> Current harmful use of illegal substances and/or alcohol
- •> Performed bariatric surgery
- •> Current or within the past 6 months use of medications which, according to the assessment of the study physician, favor obesity or influence body
- •weight and affect energy and glucose balance (e.g. steroids, antiepileptic drugs, psychotropic drugs, appetite suppressants) as well as
- •immunosuppressants.
- •o Pathological results of laboratory examination at screening:
- •> Advanced renal insufficiency (GFR <45 ml/min or assessed or known to be so by study physician).
- •> Advanced hepatic insufficiency (elevation of transaminases above 3 times normal or assessed or known to be so by study physician).
- •> Additional laboratory parameters assessed by the study physician as critical for study participation
- •o History of or existing retinal detachment
- •o Presence of any secondary form of obesity (incl. polycystic ovary syndrome, Cushing's syndrome, Prader-Willi syndrome, hypogonadism, Lauren-Moon-Biedl-Bardet syndrome, acromegaly, hypothalamic-pituitary hormone axis disorders).
- •o Physician-ordered other form of diet (e.g. for celiac disease).
- •o Active or recent participation in another weight loss program (with weight loss of more than 5% body weight in the past 3 months).
- •o Lack of suitability for study participation assessed by the study physician.
- •o Concurrent participation in another intervention study or participation in another intervention study within the last 3 months.
研究者
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