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治験 NCT07495904 (LEAN-PRO GLP-1)（対象：肥満）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
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) 130 無作為化 食事療法
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07495904 (LEAN-PRO GLP-1) は 介入研究 臨床試験 で、肥満 に関するものです。現在は 募集中 で、2026年3月30日 から開始しています。130 名の参加者 の募集が計画されています。この試験は Hellenic Mediterranean University によって主導され、2029年1月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年4月2日 です。
概要
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 ...
もっと見る詳細説明
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...もっと見る
公式タイトル
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
疾患名
肥満その他の研究識別子
- LEAN-PRO GLP-1
- 159302
- Protocol No. 44248 (その他の識別子) (University General Hospital of Heraklion (PAGNI))
NCT番号
開始日
2026-03-30
最終更新日
2026-04-02
終了予定日
2029-01-30
目標参加者数
130
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
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
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬GLP-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. |
実験的GLP-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. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
30 Years
対象性別
全て
- 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 Heraklion責任者
Christopher Papandreou, 主任研究者, Assistant Professor, Department of Nutrition & Dietetics Sciences, Hellenic Mediterranean University
試験中央連絡先
連絡先: Ioanna Charalampidou, +302810379242, [email protected]
連絡先: Christopher Papandreou
2 1カ国の場所
1st Department of Internal Medicine, University General Hospital of Heraklion, Heraklion, Greece
Theodosios Filippatos, 連絡先, +302813402360
Theodosios Filippatos, 主任研究者
募集中
Human Dietetics & Body Composition Laboratory, Department of Nutrition and Dietetics Sciences, Hellenic Mediterranean University, Heraklion, Greece
Ioanna Charalampidou, 連絡先, +302810379242, [email protected]
Christopher Papandreou, 主任研究者
Ioanna Charalampidou, 副研究者
Vasileios Zafiropoulos, 副研究者
募集中