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Does Estrogen Blunt the Effects of Exercise Training on Glycemic Control

2026年8月25日 更新者：Michaela Devries-Aboud、University of Waterloo

The Impact of 17beta-estradiol Treatment on Insulin Sensitivity, Immune Function, Inflammation and Skeletal Muscle Metabolism Following Exercise Training in Sedentary, Overweight Males

Previous research has found that males and females respond differently to exercise training, particularly with respect to improvements in blood sugar control and immune system health. This is crucial since insulin resistance, which can lead to type 2 diabetes and other health problems, affects millions of Canadians. People with insulin resistance often have higher inflammation. Exercise is known to improve insulin resistance and reduce inflammation, but females seem to benefit less from exercise compared to men. The investigators believe this difference might be due to estrogen, a hormone that helps regulate blood sugar (in non-exercising conditions) and reduce inflammation. Females have higher estrogen levels, which might explain their ability to regulate resting blood sugar control and also immune function at rest. Our research will investigate how estrogen influences the acute and chronic effects of exercise males. The investigators will study how estrogen influence's the body's response to exercise, particularly in terms of reducing inflammation and improving blood sugar levels as well as immune function. Overweight and obese males will undergo 2 weeks of high intensity interval training while taking either an estrogen supplement or placebo. Prior to and following training males will undergo an assessment of maximal fitness (VO2max test) and an oral glucose tolerance test. Prior to and following the acute exercise test blood samples will be taken to determine the acute effects of exercise on immune cell function and inflammation. Prior to and during the oral glucose tolerance test participants will have blood samples taken to determine glucose handling and insulin sensitivity. They will also have a muscle biopsy taken prior to and 1h into the oral glucose tolerance test to determine the effects of estrogen supplementation on insulin signaling, mitochondrial content and function, fat metabolism and fat storage in skeletal muscle.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

24

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 加拿大
    • Ontario
      • Waterloo、Ontario、加拿大、N2L 3G1
        • University of Waterloo
        • 接触：
        • 首席研究员：
          • Michaela Devries-Aboud, PhD
        • 副研究员：
          • Vito Pipitone, PhD Candidate
        • 副研究员：
          • Emma Dare, PhD
        • 副研究员：
          • Madeline Noble, MSc
        • 副研究员：
          • Sean Gartner, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Biological males (with no previous hormonal supplementation).
  • Between the ages of 18-35 years old
  • Non-smokers
  • Sedentary individuals (i.e., engaging in intentional moderate-to-vigorous physical activity <2x/week)
  • Body mass index 27-32 kg/m2
  • Body fat % > 22%

Exclusion Criteria:

  1. Any state that can impact the hormonal milieu (e.g., drug/hormonal supplementation related to health).
  2. Usage of anti-inflammatory medications, >1 glucose lowering medications, insulin, platelet inhibitors, anti-coagulant medications or simvastatin, beta-blockers, weight loss medications (Orlistat, Saxenda, Contrave, Ozempic) or any medications known to affect protein metabolism (i.e., corticosteroids).
  3. Presence of cardiovascular, respiratory, metabolic, autoimmune or renal disease.
  4. Presence of any condition that makes the participant unable to participate in physical activity as determined using the CSEP Get Active Questionnaire.
  5. Presence of injury that restricts exercise performance.
  6. VO2max > 50th percentile for age.
  7. Previous (within the last 2 months) or current use of ergogenic aids (i.e. creatine).
  8. Previous or current use of weight loss medications, including liraglutide, semaglutide, orlistat, ozempic, etc.
  9. History and/or diagnosis of blood clots or family history of blood clot disorders.
  10. History of allergies or sensitivities to local anesthetic
  11. Ophthalmic vascular disease
  12. Classical migraines
  13. History of thromboembolic disease
  14. Consume 15 or more alcoholic drinks/week or 3 drinks per day
  15. Bleeding disorders
  16. Severe peripheral neuropathy
  17. Muscular dystrophy
  18. Prior bariatric surgery
  19. Osteoporosis/osteopenia
  20. Orthopaedic issues
  21. Presence of GI disorders (i.e., Colitis, Crohns disease, Celiac disease)
  22. Presence of liver disease or dysfunction (i.e., diagnosed NAFLD, NASH, cirrhosis, previous liver transplant)
  23. History of cancer
  24. Type 1 or 2 diabetes
  25. Presence of renal disorders (creatinine > 140)
  26. Uncontrolled hypertension (>140/90 mmHg)
  27. History of allergies or sensitivities to estradiol or to any ingredient in the formulation or component of the container
  28. History and/or diagnosis of blood clots or family history of blood clot disorders
  29. Have an implantable electronic device
  30. Medical psychiatric history of depression, bipolar, anxiety, suicidal ideation, etc.
  31. Inherited clotting disorders
  32. Chest pain or shortness of breath
  33. Inflammatory disorders (e.g., inflammatory bowel disorder)
  34. Significant weight loss in the 3-month period prior to the study (10% of total body weight)
  35. Any kind of major surgery recently
  36. Bleeding disorders
  37. Active or history of thromboembolic disease (including confirmed venous thromboembolism)
  38. Ophthalmic vascular disease
  39. Classical migraines

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Estrogen
1mg/d 17-beta estradiol x 2 day and 2mg/d 17-beta estradiol for 14 days
其他：EXERCISE TRAINING WITH OR WITHOUT MEDICATION
2 weeks of high intensity interval training while either taking estrogen or placebo
安慰剂比较：Placebo
400mg/d of glucose polymer x 16 days
其他：EXERCISE TRAINING WITH OR WITHOUT MEDICATION
2 weeks of high intensity interval training while either taking estrogen or placebo

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Glucose AUC
大体时间：Visit 3 (baseline) and Visit 11 (Day 16)
Glucose AUC determined from blood samples taken during a 2h oral glucose tolerance test
Visit 3 (baseline) and Visit 11 (Day 16)

次要结果测量

结果测量
措施说明
大体时间
Insulin resistance/sensitivity
大体时间：Visit 3 (baseline) and Visit 11 (Day 16)
at rest (HOMA-IR) and during a 2 h oral glucose tolerance test (Matsuda index)
Visit 3 (baseline) and Visit 11 (Day 16)
Markers of insulin signaling
大体时间：Visit 3 (baseline) and Visit 11 (Day 16)
Western blot of the following markers: AMPKα Thr172 & total AMPKα; phosphorylated Akt Ser437 & total Akt; phosphorylated TBC1D4 Thr642 & total TBC1D4; phosphorylated TBC1D1 Ser237 & total TBC1D; total GLUT4 in human skeletal muscle in the fasted and insulin stimulated state
Visit 3 (baseline) and Visit 11 (Day 16)
Membrane bound GLUT4
大体时间：Visit 3 (baseline) and Visit 11 (Day 16)
GLUT4 content at the membrane in the fasted and insulin stimulated state (determined via immunofluorescence)
Visit 3 (baseline) and Visit 11 (Day 16)
Peripheral blood mononuclear cells
大体时间：Visit 2 (baseline) and Visit 10 (Day 14)
determination of immune cell response to acute exercise
Visit 2 (baseline) and Visit 10 (Day 14)
Plasma cytokines from isolated PBMCs
大体时间：Visit 2 (baseline) and Visit 10 (Day 14)
pro- and anti-inflammatory cytokine content will be determine using a cytokine array and commercially available kits
Visit 2 (baseline) and Visit 10 (Day 14)
Mitochondrial content
大体时间：Visit 3 (baseline) and Visit 11 (Day 16)
determined using electron microscopy
Visit 3 (baseline) and Visit 11 (Day 16)
Mitochondrial respiration
大体时间：Visit 3 (baseline) and Visit 11 (Day 16)
skeletal muscle mitochondrial respiration determined using high-resolution respirometry
Visit 3 (baseline) and Visit 11 (Day 16)
intramyocellular lipid (IMCL) content
大体时间：Visit 3 (baseline) and Visit 11 (Day 16)
total and subcellular location-specific content and storage characteristics
Visit 3 (baseline) and Visit 11 (Day 16)
aerobic fitness (VO2max)
大体时间：Visit 2 (baseline) and Visit 10 (Day 14)
VO2max determined during a graded exercise test
Visit 2 (baseline) and Visit 10 (Day 14)
Sex hormone concentrations
大体时间：Visit 3 (baseline) and Visit 11 (Day 16)
Serum estradiol measured using commercially available kits
Visit 3 (baseline) and Visit 11 (Day 16)
Serum hormone concentrations
大体时间：Visit 3 (baseline) and Visit 11 (Day 16)
Serum progesterone measured using commercially available kits
Visit 3 (baseline) and Visit 11 (Day 16)
Sex hormone concentrations
大体时间：Visit 3 (baseline) and Visit 11 (day 16)
Serum testosterone measured using commercially available kits
Visit 3 (baseline) and Visit 11 (day 16)
Serum hormone concentrations
大体时间：Visit 2 (baseline) and visit 10 (day 14)
Serum growth hormone measured using commercially available kits prior to a maximal graded exercise test and immediately (t=0 min), 30 and 60 min after the graded exercise test.
Visit 2 (baseline) and visit 10 (day 14)
Serum hormone concentrations
大体时间：Visit 2 (baseline) and visit 10 (Day 14)
Serum glucagon measured using commercially available kits prior to a maximal graded exercise test and immediately (t=0 min), 30 and 60 min after the graded exercise test.
Visit 2 (baseline) and visit 10 (Day 14)
Neurotransmitter concentration
大体时间：Visit 2 (baseline) and Visit 10 (day 14)
Serum epinephrine concentration measured using a commercially available kit prior to a maximal graded exercise test and immediately (t=0 min), 30 and 60 min after the graded exercise test.
Visit 2 (baseline) and Visit 10 (day 14)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Waterloo

调查人员

  • 首席研究员：Michaela Devries, PhD、University of Waterloo

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年4月1日

研究注册日期

首次提交

2026年8月14日

首先提交符合 QC 标准的

2026年8月25日

首次发布 (实际的)

2026年8月27日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 46726

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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