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治験 NCT06546085（対象：2型糖尿病、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
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Extracellular Vesicles, Insulin Action, and Exercise
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 NCT06546085 は 介入研究 臨床試験 で、2型糖尿病、肥満 に関するものです。現在は 募集中 で、2025年2月10日 から開始しています。60 名の参加者 の募集が計画されています。この治験は Rutgers, The State University of New Jersey によって主催され、2029年4月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年7月3日 です。
概要
Extracellular vesicles (EVs) play a role in obesity-induced insulin resistance and likely impact the development of cardiovascular disease. However, little is known on how EVs affect vascular insulin action in people. The purpose of this study is to understand how EVs play a role in type 2 diabetes related cardiovascular disease. This research will also study if exercise can change how EVs impact blood flow and metabolic health. This study will contribute to designing precision medicine to treat/prevent cardiovascular disease in type 2 diabetes.
詳細説明
Insulin resistance is a key underlying factor promoting hyperglycemia and hypertension in people with type 2 diabetes (T2D), who have a 3-fold greater cardiovascular disease (CVD) risk when compared with healthy controls. Despite several therapeutic approaches that favor insulin sensitivity through a variety of purported mechanisms (e.g. weight loss, incretins, AMPK activation, reduction in bioactive lipids: DAG/ceramides, etc.), long-term progression of glucose deterioration occurs. This suggests adjunctive targets may be important to prevent/reverse T2D. Studies show that extracellular vesicles (EVs) obtained from plasma are involved in obesity-induced insulin resistance at levels of adipocytes, muscle, and liver. However, little is known how plasma EVs affect vascular insulin action in humans. This is of clinical relevance as EVs enhance the Framingham Risk Score, suggesting EVs are a unique factor promoting CVD. This proposal will fill this knowledge gap by conducting a translational study in 3 distinct groups of people separated by obesity and T2D. The investigators hypothesize that 1) insulin will promote EV uptake and modify insulin signaling in endothelial cells, 2) EVs from adults with T2D will impair vessel reactivity compared to controls; 3) insulin will alter circulating EV insulin signaling and cargo, and 4) exercise training will change EV uptake and cargo as well as EV mediated vascular reactivity to insulin as well as relate to improved vascular function in humans.
公式タイトル
Extracellular Vesicles, Insulin Action, and Exercise on Vascular Function in Type 2 Diabetes
疾患／病気
2型糖尿病肥満刊行物
この臨床試験について発表された科学記事と研究論文：- Zhang M, Wang L, Chen Z. Research progress of extracellular vesicles in type 2 diabetes and its complications. Diabet Med. 2022 Sep;39(9):e14865. doi: 10.1111/dme.14865. Epub 2022 May 20.
- Nozaki T, Sugiyama S, Koga H, Sugamura K, Ohba K, Matsuzawa Y, Sumida H, Matsui K, Jinnouchi H, Ogawa H. Significance of a multiple biomarkers strategy including endothelial dysfunction to improve risk stratification for cardiovascular events in patients at high risk for coronary heart disease. J Am Coll Cardiol. 2009 Aug 11;54(7):601-8. doi: 10.1016/j.jacc.2009.05.022.
- Ragland TJ, Heiston EM, Ballantyne A, Stewart NR, La Salvia S, Musante L, Luse MA, Isakson BE, Erdbrugger U, Malin SK. Extracellular vesicles and insulin-mediated vascular function in metabolic syndrome. Physiol Rep. 2023 Jan;11(1):e15530. doi: 10.14814/phy2.15530.
- Heiston EM, Ballantyne A, Stewart NR, La Salvia S, Musante L, Lanningan J, Erdbrugger U, Malin SK. Insulin infusion decreases medium-sized extracellular vesicles in adults with metabolic syndrome. Am J Physiol Endocrinol Metab. 2022 Oct 1;323(4):E378-E388. doi: 10.1152/ajpendo.00022.2022. Epub 2022 Jul 20.
- Heiston EM, Ballantyne A, La Salvia S, Musante L, Erdbrugger U, Malin SK. Acute exercise decreases insulin-stimulated extracellular vesicles in conjunction with augmentation index in adults with obesity. J Physiol. 2023 Nov;601(22):5033-5050. doi: 10.1113/JP282274. Epub 2022 Feb 16.
- Eichner NZM, Gilbertson NM, Heiston EM, Musante L, LA Salvia S, Weltman A, Erdbrugger U, Malin SK. Interval Exercise Lowers Circulating CD105 Extracellular Vesicles in Prediabetes. Med Sci Sports Exerc. 2020 Mar;52(3):729-735. doi: 10.1249/MSS.0000000000002185.
- Hallmark R, Patrie JT, Liu Z, Gaesser GA, Barrett EJ, Weltman A. The effect of exercise intensity on endothelial function in physically inactive lean and obese adults. PLoS One. 2014 Jan 20;9(1):e85450. doi: 10.1371/journal.pone.0085450. eCollection 2014.
- Steinberg HO, Chaker H, Leaming R, Johnson A, Brechtel G, Baron AD. Obesity/insulin resistance is associated with endothelial dysfunction. Implications for the syndrome of insulin resistance. J Clin Invest. 1996 Jun 1;97(11):2601-10. doi: 10.1172/JCI118709.
- Solomon TP, Malin SK, Karstoft K, Haus JM, Kirwan JP. The influence of hyperglycemia on the therapeutic effect of exercise on glycemic control in patients with type 2 diabetes mellitus. JAMA Intern Med. 2013 Oct 28;173(19):1834-6. doi: 10.1001/jamainternmed.2013.7783. No abstract available.
その他の研究識別子
- Pro2024000230
- R01DK133598-01A1 (米国NIHの助成金/契約)
主目的
基礎研究
割付方法
非無作為化
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 |
|---|---|
非介入Lean with Normal Glucose Tolerance Participants will not receive the study intervention and will be healthy controls. | 該当なし |
実験的Obesity with Normal Glucose Tolerance Participants with obesity and normal glucose tolerance will participate in 3 supervised exercise training sessions at 85% VO2max that expends \~400 kcal for 16 weeks. | 運動 Supervised treadmill exercise at 85% VO2max, 3x/wk for 16 weeks. Exercise duration will be adjusted based on individual VO2-heart rate (HR) relationship so that \~400 kcals will be expended during each training session. |
実験的Obesity with Type 2 Diabetes Participants with obesity and type 2 diabetes will participate in 3 supervised exercise training sessions at 85% VO2max that expends \~400 kcal for 16 weeks. | 運動 Supervised treadmill exercise at 85% VO2max, 3x/wk for 16 weeks. Exercise duration will be adjusted based on individual VO2-heart rate (HR) relationship so that \~400 kcals will be expended during each training session. |
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 in Extracellular Vesicles during insulin infusion | Extracellular vesicles (CD41 -CD31+, CD45, Tx, CD31, CD105) will be isolated from plasma before and during insulin stimulation. | From enrollment to the end of treatment at 16 weeks. |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Metabolic Insulin Sensitivity by the Isoglycemic Clamp | Measure of glucose metabolism determined by the glucose infusion during the last 30 minutes of the 150 clamp procedure. | From enrollment to the end of treatment at 16 weeks. |
Change in Contrast Enhanced Ultrasound | Measure of microvascular blood flow before and during insulin stimulation. | From enrollment to the end of treatment at 16 weeks. |
Change in Flow Mediated Dilation of the brachial artery | Measure of blood flow using ultrasound before and during insulin stimulation. | From enrollment to the end of treatment at 16 weeks. |
Change in Pulse Wave Velocity | Measure of arterial stiffness using pulse waves at the carotid and femoral arteries before and during insulin stimulation. | From enrollment to the end of treatment at 16 weeks. |
Change in Augmentation Index | Measure of aortic pressure waveforms before and during insulin stimulation. | From enrollment to the end of treatment at 16 weeks. |
Change in Post Ischemic Flow Velocity in the brachial artery | Measure of blood flow using ultrasound before and during insulin stimulation. | From enrollment to the end of treatment at 16 weeks. |
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
- Male or female 30 - 80 years old.
- HbA1c <5.7% and fasting glucose <100mg/dl to be considered NGT
- T2D diagnosis or confirmation HbA1c ≥6.5% and fasting glucose ≥126 mg/dl
- Prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors ≥1 year.
- Has a body mass index of 20-25 or 28-45 kg/m2.
- Not diagnosed with Type 1 diabetes.
- Not currently engaged in >150 min/wk of exercise.
- Participants with morbid obesity (BMI >45 kg/m2) and under-/overweight patients (BMI: ≤18 or 25-27.99 kg/m2).
- Intolerance to insulin
- Evidence of type 1 diabetes and diabetics requiring insulin therapy.
- Participants who have not been weight stable (≥2 kg weight change in past 6 months)
- Participants who have been recently active in past 6 months via health screening questions (≥150 min of moderate/high intensity exercise)
- T2D with HbA1c ≥8.0%
- Participants who are smokers or who have quit smoking ≤5 years ago
- Participants prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors within 1 year.
- Hypertriglyceridemic (≥400 mg/dl) and hypercholesterolemic (≥260 mg/dl) participants as determined from LabCorp samples.
- Kidney dysfunction as determined from LabCorp biochemical outcomes (e.g. creatinine (≥1.0 mg/dl), eGFR (≤59 ml/min/1.73), BUN (≥24 mg/dl) as derived from comprehensive metabolic panels).
- Hypertensive (≥160/100 mmHg) at time of screening.
- Abnormal liver function (reflective from comprehensive panel liver enzymes Alk (≥121 IU/L), AST (≥40 IU/L) and ALT (≥32 IU/L) via LabCorp).
- History of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures, or impact subject safety.
- Pregnant (as evidenced by positive pregnancy test) or nursing women
- Participants with contraindications to participation in an exercise training program
- Known hypersensitivity to perflutren (contained in Definity).
- Anemic as confirmed by hematocrit (HCT) (women ≤36%, Men ≤38%) at time of screening.
- Suggested infections at time of screening as confirmed by WBC (≥10.8 x10E3/uL) and/or platelets (≥450 x10E3/uL).
Rutgers, The State University of New Jersey- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- バージニア大学296 件のアクティブな治験を探索
責任者
Steven K Malin, PhD, 研究責任者, Associate Professor, Rutgers, The State University of New Jersey
試験中央連絡先
連絡先: Steven K Malin, PhD, 848-932-7540, [email protected]
連絡先: Emily M Heiston, PhD, 848-932-7540, [email protected]
3 1カ国の場所
New Jersey
Institute for Food, Nutrition, and Health, New Brunswick, New Jersey, 08901, United States
Sue Shapses, PhD, 連絡先, 848-932-9403, [email protected]
募集中
Robert Wood Johnson University Hospital Clinical Research Center, New Brunswick, New Jersey, 08901, United States
Fei Chen, 連絡先, 732-235-5966, [email protected]
募集中
Rutgers University Loree Gymnasium, New Brunswick, New Jersey, 08901, United States
Steven K Malin, PhD, 連絡先, 848-932-7540, [email protected]
募集中