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治験 NCT04754581 (EXPET)（対象：2型糖尿病）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
Dynamic in Vivo PET Imaging and ex Vivo Biopsies From Skeletal Muscle and Adipose Tissue to Investigate the Effects of Exercise on Insulin Resistance and Mitochondrial Energetics in Type 2 Diabetes (EXPET)
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」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 NCT04754581 (EXPET) は 介入研究 臨床試験 で、2型糖尿病 に関するものです。現在は 募集中 で、2021年3月30日 から開始しています。12 名の参加者 の募集が計画されています。この治験は AdventHealth Translational Research Institute によって主催され、2025年6月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2024年9月27日 です。
概要
The overall aim of this pilot study is to investigate the effects of exercise training on skeletal muscle and adipose tissue insulin resistance in subjects with Type 2 Diabetes (T2D).
公式タイトル
Dynamic in Vivo PET Imaging and ex Vivo Biopsies From Skeletal Muscle and Adipose Tissue to Investigate the Effects of Exercise on Insulin Resistance and Mitochondrial Energetics in Type 2 Diabetes
疾患／病気
2型糖尿病その他の研究識別子
- EXPET
- 1581803
主目的
その他
割付方法
該当なし
介入モデル
単一群割当
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 |
|---|---|
その他All Participants | Maximal ATP Production (ATPMAX) ATPmax will be measured in order to determine in vivo mitochondrial capacity. The magnetic resonance scans to measure mitochondrial energetics will also be performed. Exercise Testing (VO2MAX) Aerobic fitness level will be assessed while participant pedals on a stationary bicycle/walk on a treadmill. The volume of oxygen intake and carbon dioxide (CO2) production will be measured. 筋生検 Sample muscle cells from the left leg Vastus Lateralis (thigh) muscle. 脂肪組織生検 Sample fat tissue from the abdomen. Hyperinsulinemic Euglycemic Clamp Measurement of insulin sensitivity. PET画像 After an overnight fast, an intravenous catheter will be placed in each arm (one with arterial line for PET infusion, and the other for infusion of insulin, glucose, and 6,6 D2 glucose tracer. FDG-glucose will be injected followed by 90-minute PET scanning of the thigh. |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Individual steps of muscle glucose uptake (pre-exercise) | Muscle glucose uptake will be assessed two times (pre and post exercise intervention) on the biceps femoris and vastus lateralis through PET imaging and hyperinsulinemic euglycemic clamp. | 24 hours |
Individual steps of muscle glucose uptake (post-exercise) | Muscle glucose uptake will be assessed two times (pre and post exercise intervention) on the biceps femoris and vastus lateralis through PET imaging and hyperinsulinemic euglycemic clamp. | 24 hours |
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
健康なボランティアを受け入れる
はい
- Age 30-65 years
- Men and women
- Body mass index (BMI) between 25 and 45 kg/m2
- Sedentary (1 day or less per week of structured exercise)
- Type 2 diabetes mellitus determined by self-report or by a fasting glucose >126mg/dl
- Weight stable (± 2 kg) for prior 3 months
- Willing to commit to the schedule of assessment visits, including the exercise intervention
- Currently taking insulin, injectable incretin mimetics and thiazolidinediones
- Taking more than two glucose-lowering medications
- Resting blood pressure ≥ 160/100 mm Hg
- Triglycerides ≥ 500 mg/dL
- Any renal, cardiac, liver, lung, or neurological disease that in the opinion of the principal investigator would compromise participant safety or the participants' ability to complete the exercise training protocol
- Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)
- Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise training
- Pulse check ("Allen test") indicates participant has poor blood flow in the hands
- Cancer (active malignancy with or without concurrent chemotherapy; except for basal cell carcinoma)
- Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next year
- Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
- Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures
- Participant is currently taking anti-inflammatory medication or has had inflammatory medication within 1 week prior to screening (including over the counter formulations: e.g. Aleve, Motrin, Ibuprofen, Naproxen, low dose ASA.
- New onset (<3 months on a stable regime) hormone replacement therapy
- Current use of beta-adrenergic blocking agents
- Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
- Increased liver function tests (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal)
- Abnormal blood count/anemia, blood transfusion or blood donation within the last 2 months
- Current smokers (smoking within the past 3 months prior to screening visit, including any/all tobacco products)
- Current drug or alcohol abuse/dependence
- Metal implants (pace-maker, aneurysm clips) based on investigator's judgment at screening
- Not physically capable of performing the exercise required of the study protocols
- Plans to be away >2 weeks in the next 3 months
- Unable to participate in Magnetic Resonance Imaging (MRI) assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on investigator's judgment at screening.
- Unable to tolerate MRI or claustrophobia.
- Nickel allergy
- Lidocaine allergy
- Unable or unwilling to communicate with staff or to provide written informed consent
AdventHealth Translational Research Institute試験中央連絡先
連絡先: Recruitment Department, 407-303-7100, [email protected]
1 1カ国の場所
Florida
AdventHealth Translational Research Institute, Orlando, Florida, 32804, United States
Recruitment Department, 連絡先, 407-303-7100, [email protected]
募集中