رادار التجارب AI | ||
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حالة التجربة السريرية NCT07495904 (LEAN-PRO GLP-1) لـ السمنة هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
Effect of GLP-1 Receptor Agonists on Body Composition in Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance (LEAN-PRO GLP-1) ١٣٠ عشوائية نظام غذائي
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT07495904 (LEAN-PRO GLP-1) هي دراسة تدخُّلية لـالسمنة وهي يقبل مشاركين. بدأت في ١١ شوال ١٤٤٧ هـ مع خطة لتجنيد ١٣٠ مشاركًا. يقودها Hellenic Mediterranean University، ومن المتوقع اكتمالها بحلول ١٥ رمضان ١٤٥٠ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٤ شوال ١٤٤٧ هـ.
الملخص
This study investigates how weight-loss medications, specifically GLP-1 receptor agonists, affect body composition, with a special focus on preserving muscle mass in adults with obesity. While these medications are highly effective for weight loss, they can sometimes lead to an unwanted loss of valuable muscle mass (a condition that can lead to sarcopenia).
To explore how to prevent this, researchers are conducting ...
عرض المزيدوصف مفصل
Obesity is a global public health challenge. While weight loss is essential, preserving Muscle Mass (MM) is crucial for maintaining metabolic health, functional capacity, and long-term treatment outcomes. Although Glucagon Like Peptide- 1 Receptor Agonists (GLP-1 RAs) are highly effective for weight reduction, significant loss of lean mass raises concerns regarding sarcopenic obesity, especially in vulnerable populat...عرض المزيد
العنوان الرسمي
The Effect of GLP-1 Receptor Agonist-based Treatment on Body Composition and Muscle Mass in Adults With Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance
الحالات الطبية
السمنةمعرّفات دراسة أخرى
- LEAN-PRO GLP-1
- 159302
- Protocol No. 44248 (معرف آخر) (University General Hospital of Heraklion (PAGNI))
NCT معرّف
تاريخ البدء (فعلي)
2026-03-30
آخر تحديث مُنشور
2026-04-02
تاريخ الاكتمال (المقدر)
2029-01-30
عدد المشاركين المخطط لهم
١٣٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
يقبل مشاركين
الكلمات الرئيسية
Body composition
pharmacologically induced weight loss
GLP-1 receptor agonists
muscle mass
dietary protein
pharmacologically induced weight loss
GLP-1 receptor agonists
muscle mass
dietary protein
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
مقارن نشطGLP-1 + Standard Diet Participants will receive GLP-1 treatment alongside standard nutritional counseling based on the Mediterranean diet pattern, provided within the framework of usual clinical practice. | Control (Standard Mediterranean Diet Counseling) Standard nutritional counseling based on the Mediterranean diet pattern as part of usual clinical practice. |
تجريبيةGLP-1 + High Protein Diet Participants will receive GLP-1 treatment along with a specialized dietary intervention featuring individualized guidelines aimed at increasing daily protein intake. | High Protein Dietary Intervention Individualized dietary guidelines focusing on increased protein consumption to preserve muscle mass during weight loss. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change from Baseline in Muscle Mass | Evaluation of the change in Muscle Mass using a multi-compartment body composition model (4C/5C). This gold-standard approach integrates data from Underwater Weighing (Body Density), Dual-Energy X-ray Absorptiometry (DEXA, for Bone Mineral Content), and Bioelectrical Impedance Spectroscopy (BIS, for Total Body Water) to provide a precise estimation of muscle mass. Results will be reported in kilograms (kg) | Baseline and End of Intervention (up to 24 weeks) |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change from Baseline in Body Composition Parameters | Assessment of changes in Fat Mass (FM), Fat-Free Mass (FFM), Total Body Protein (TBPro), Total Body Water (TBW), Intracellular Water (ICW), Extracellular Water (ECW), and hydration of FFM, utilizing the 4- and 5- Compartment models.
Assessment of changes in body composition utilizing the 4- and 5-Compartment models. The parameters evaluated include Fat-Free Mass (FFM) and Total Body Protein (TBPro), which will be reported in kilograms (kg). Fat Mass (FM) will be reported both in kilograms (kg) and as a Body Fat Percentage (%). Total Body Water (TBW), Intracellular Water (ICW), and Extracellular Water (ECW) will be reported in liters (L) and as a percentage (%). The hydration of FFM will be reported as a percentage (%). | Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention |
Change from Baseline in Biochemical and Urinary Markers | Assessment of changes in systemic biomarkers. Blood markers include glycemic control (Fasting Glucose, Insulin \[reported in mg/dL or μU/mL\], HbA1c \[%\]), lipid profile (Total, HDL, LDL Cholesterol, Triglycerides \[mg/dL\]), renal/hepatic function (Creatinine, Urea, Bilirubin \[mg/dL\], ALT \[U/L\]), thyroid function (TSH \[mIU/L\]), inflammatory markers (CRP \[mg/L\]), and micronutrient status (B12, Vit D3, Folic Acid, Calcium, Magnesium \[reported in standard clinical units, e.g., pg/mL, ng/mL, mg/dL\]). Urinary biomarkers (Urinary Urea Nitrogen, Albumin, Creatinine) will also be assessed and reported in standard units (e.g., mg/dL, g/24h). | Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention |
Long-term Weight Maintenance Efficiency | Evaluation of the sustainability of the intervention results after treatment cessation. This measure primarily tracks the change in Body Weight to assess potential weight regain during the follow-up phase. The preservation of Muscle Mass (MM) and Fat Mass (FM) will also be monitored. Changes in Body Weight, MM, and FM will be reported in kilograms (kg) and as a percentage (%) of the weight/mass lost during the active intervention phase. | From End of Intervention (up to 24 weeks) to 6 months post-intervention |
Change from Baseline in Sarcopenia Risk | Participants will be classified as "at risk" for early sarcopenia if they meet at least one of the following criteria:
1. SARC-F score ≥4 (on a scale of 0-10)
2. Handgrip strength below the EWGSOP2 thresholds (men \<27 kg, women \<16 kg)
Evaluation of sarcopenia risk using a combination of the Greek validated SARC-F questionnaire and handgrip strength measured via a calibrated dynamometer. The SARC-F score ranges from 0 to 10, where higher scores indicate a greater risk of sarcopenia (worse outcome). Handgrip strength will be reported in kilograms (kg). Participants will be classified as "at risk" for early sarcopenia based on the EWGSOP2 criteria if they meet at least one of the following:
1. SARC-F score ≥ 4, or
2. Handgrip strength below the gender-specific thresholds (men \< 27 kg, women \< 16 kg).
The overall outcome will be reported as the change in the continuous parameters (SARC-F score and grip strength in kg) and the proportion (%) of participants classified as "at risk". | Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention |
Change from Baseline in Energy and Macronutrient Intake | Assessment of total energy intake and macronutrient distribution to evaluate dietary adherence. Data will be collected via three-day 24-hour dietary recalls (two weekdays and one weekend day). Total energy intake will be reported in kilocalories (kcal). Macronutrient distribution (specifically protein, carbohydrates, and fats) will be reported in absolute amounts (grams, g) and as a relative proportion of the diet (percentage, %, of total energy intake). | Baseline, End of Intervention (up to 24 weeks), and at 6 months post-intervention |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
30 Years
الجنس المؤهل
الكل
- Adults 30-65 years old
- BMI: ≥30 kg/m²
- Signed Informed Consent
A. Metabolic and Medical Conditions:
- Uncontrolled type 2 diabetes (HbA1c > 9.0%)
- Known cardiovascular disease (e.g., coronary artery disease, heart failure NYHA 3-4)
- Chronic kidney disease stage 4-5 (GFR <60 ml/min)
- Liver disease (known hepatitis, ALT ≥ 3 or total bilirubin ≥ 2 times ULN)
- Inflammatory bowel disease
- Celiac disease
- History of pancreatitis
- Any disorder potentially causing malabsorption
- Active cancer or history of malignancy within the past 3 years
- Psychiatric disorders affecting adherence or assessment B. Medication and Supplement Use
- Chronic use of medications affecting metabolism or body composition (e.g., corticosteroids, anti-obesity drugs)
- Use of anti-inflammatory or antioxidant medications
- Use of probiotics, prebiotics, or laxatives within the last month
- Unstable medication regimen (changes within the past 3 months)
- Use of protein and creatine supplements.
C. Dietary and Lifestyle Factors:
- Alcohol or substance abuse
- Engagement in intense regular physical activity
D. Reproductive Status:
- Pregnancy or breastfeeding
- Pregnancy within the past 12 months
- Plans to become pregnant during the study
E. Other:
- Any condition that, in the opinion of the Investigator, may interfere with participation, adherence, or the interpretation of study results.
Hellenic Mediterranean UniversityUniversity General Hospital of Heraklionالجهة المسؤولة عن الدراسة
Christopher Papandreou, المحقق الرئيسي, Assistant Professor, Department of Nutrition & Dietetics Sciences, Hellenic Mediterranean University
جهة اتصال مركزية للدراسة
جهة اتصال: Ioanna Charalampidou, +302810379242, [email protected]
جهة اتصال: Christopher Papandreou
2 مواقع الدراسة في 1 بلدان
1st Department of Internal Medicine, University General Hospital of Heraklion, Heraklion, Greece
Theodosios Filippatos, جهة اتصال, +302813402360
Theodosios Filippatos, المحقق الرئيسي
يقبل مشاركين
Human Dietetics & Body Composition Laboratory, Department of Nutrition and Dietetics Sciences, Hellenic Mediterranean University, Heraklion, Greece
Ioanna Charalampidou, جهة اتصال, +302810379242, [email protected]
Christopher Papandreou, المحقق الرئيسي
Ioanna Charalampidou, محقق فرعي
Vasileios Zafiropoulos, محقق فرعي
يقبل مشاركين