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Does Estrogen Blunt the Effects of Exercise Training on Glycemic Control

25 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

24

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • University of Waterloo
        • Contatto:
        • Investigatore principale:
          • Michaela Devries-Aboud, PhD
        • Sub-investigatore:
          • Vito Pipitone, PhD Candidate
        • Sub-investigatore:
          • Emma Dare, PhD
        • Sub-investigatore:
          • Madeline Noble, MSc
        • Sub-investigatore:
          • Sean Gartner, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Estrogen
1mg/d 17-beta estradiol x 2 day and 2mg/d 17-beta estradiol for 14 days
Altro: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
2 weeks of high intensity interval training while either taking estrogen or placebo
Comparatore placebo: Placebo
400mg/d of glucose polymer x 16 days
Altro: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
2 weeks of high intensity interval training while either taking estrogen or placebo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Glucose AUC
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Insulin resistance/sensitivity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Visit 3 (baseline) and Visit 11 (Day 16)
determined using electron microscopy
Visit 3 (baseline) and Visit 11 (Day 16)
Mitochondrial respiration
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Waterloo

Investigatori

  • Investigatore principale: Michaela Devries, PhD, University of Waterloo

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 aprile 2027

Completamento dello studio (Stimato)

1 aprile 2027

Date di iscrizione allo studio

Primo inviato

14 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 agosto 2026

Primo Inserito (Effettivo)

27 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 46726

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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