رادار التجارب AI | ||
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حالة التجربة السريرية NCT06511310 لـ السمنة، زيادة الوزن، مرشح لجراحة السمنة، السلوك الشهواني هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Exercise, Brain Activity, and Weight Maintenance
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06511310 هي دراسة تدخُّلية لـالسمنة، زيادة الوزن، مرشح لجراحة السمنة، السلوك الشهواني وهي قيد التجنيد. بدأت في ٢٣ ربيع الأول ١٤٤٧ هـ مع خطة لتجنيد ١٥ مشاركًا. يقودها Joslin Diabetes Center، ومن المتوقع اكتمالها بحلول ٢٦ محرم ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٢ ربيع الأول ١٤٤٧ هـ.
الملخص
This study aims to explore how HIIT influences brain function, neural and molecular pathways related to weight control, setting the stage for future obesity intervention research.
وصف مفصل
This study will include adults aged 18-70 years with a BMI >19 kg/m², both with and without prior bariatric surgery. Those with bariatric surgery must have experienced clinically significant weight regain (>10% of maximum weight lost) within 1 to 5 years post-surgery.
Participants will complete three initial clinical visits before beginning a 12-week high-intensity interval training (HIIT) program, followed by three post-training clinical visits. During visit 1, participants will undergo anthropometric assessments, baseline blood draw, oral glucose tolerance test, psychometric evaluations, and complete an MRI safety screening. At visit 2, participants will complete a resting metabolic rate assessment and a VO₂peak test. During visit 3, participants will have another baseline blood draw and undergo a functional MRI (fMRI).
The HIIT program will consist of four weekly 28-minute sessions conducted at the Joslin Diabetes and at home. Each exercise session will include a 3-minute warm-up, six rounds of 40 seconds high-intensity followed by 3 minutes of moderate intensity, and will conclude with a 3-minute cool-down.
After completing the 12-week program, participants will return for clinical visits 4-6, repeating all baseline assessments.
العنوان الرسمي
Effects of Exercise Training on Brain Activity and Its Relation to Weight Maintenance and Appetite Regulation
الحالات الطبية
السمنةزيادة الوزنمرشح لجراحة السمنةالسلوك الشهوانيمعرّفات دراسة أخرى
- 00000256
NCT معرّف
تاريخ البدء (فعلي)
2025-09-15
آخر تحديث مُنشور
2025-09-04
تاريخ الاكتمال (المقدر)
2027-07-01
عدد المشاركين المخطط لهم
١٥
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الغرض الأساسي
علوم أساسية
طريقة توزيع المشاركين
غ/م
نموذج التدخل
المجموعة الواحدة
التعمية
لا شيء (مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةExercise Training Subjects will complete a supervised high-intensity interval training program for 12 weeks, including four weekly training sessions. The training session will include a 3 minute warm-up followed by six 40 second bouts of high intensity (85-95% of VO2peak) with 3 minutes moderate intensity (45-55% of VO2peak) between each bout of high intensity, concluding with a 3 minute cool-down. Each participant's target heart rate will be specific to them, calculated from the exercise test completed during Visit 1. | تمرين High Intensity Exercise |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Changes in connectivity between brain areas following exercise training by using resting state functional MRI. | Evaluation of changes in brain function by fMRI before and after 12 weeks of exercise training. |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Changes in appetitive behavior. | Subjects will be evaluated with Three Factor Eating Questionnaire (TFEQ). | Evaluation of changes in hunger before and after 12 weeks of exercise training. |
Changes in mood. | Subjects will be evaluated with Beck Depression Inventory II (BDI-II) to assess for depressive symptoms. | Evaluation of changes in mood before and after 12 weeks of exercise training. |
Degree of changes in miRNA profiling of circulating exosomes in blood samples. | Changes in circulating exosome miRNAs will be measured using next-generation sequencing (NGS) and reported as normalized counts or fold changes relative to baseline. | Evaluation of changes in miRNA before and after 12 weeks of exercise training. |
Changes in cognitive function. | Evaluation using mini cognitive test. | Changes in cognition function before and after 12 weeks of HIIT. |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
يقبل المتطوعين الأصحاء
نعم
- Age 18-70 years
- Body mass index (BMI) >19 kg/m2 and body weight< 250kg
- Participants must have experienced a clinically significant weight regain, defined as over 10% of their maximum weight lost, within 1 to 5 years following their bariatric surgery. They will be asked to self-report their weight loss history. Participants must also provide the operative report from their bariatric surgery for reference.
- In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
- Willing to adhere to the protocol requirements for the duration of the study
- Type 1 diabetes mellitus
- Peripheral neuropathy with insensate feet
- Recent blood donation within the last 2 months
- Use of beta-blockers
- Current pregnancy or breastfeeding
- Active Heart or lung disease
- Severe hypertension (systolic >160 mmHg or diastolic >90 mmHg)
- Inability to exercise for any reason
- Any known contraindication to exercise testing based on current ACSM guidelines
- MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
- Known presence of a structural brain lesion (e.g. tumor, cortical infarct)
- Presence of another neurologic disorder, which could impact findings (e.g. multiple sclerosis)
- History of cardiovascular disease, stroke, congestive heart failure
- Active hematological, renal, pulmonary or hepatic disorders
- Active treatment for cancer
- A history of active alcohol or substance abuse
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol
- History of claustrophobia and inability to tolerate an MRI
- Body weight >250kgr and largest body diameter of 70cm as there is a certain weight and diameter limit of the MRI scanner
- Unwilling or unable to return for study visits, undergo neuropsychological testing and MRI imaging
- Left-handedness
Joslin Diabetes CenterNutrition Obesity Research Centerجهة اتصال مركزية للدراسة
جهة اتصال: Maria Vamvini, MD, 617-309-2400, [email protected]
جهة اتصال: Laura Simpson, MS, 617-735-3924, [email protected]
1 مواقع الدراسة في 1 بلدان
Massachusetts
Joslin Diabetes Center, Boston, Massachusetts, 02215, United States
Simpson, جهة اتصال, 617-735-3924, [email protected]
قيد التجنيد