Exploring hormonal and immune interactions during the menstrual cycle
Investigating the Endocrine-metabolic-immunological Axis During the Female Menstrual Cycle by Functional Genomics
University of Bonn · NCT06072391
This study is trying to see how hormonal changes during the menstrual cycle affect blood sugar and immune responses in women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 30 Years |
| Sex | All |
| Sponsor | University of Bonn (other) |
| Locations | 1 site (Bonn) |
| Trial ID | NCT06072391 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the interplay between the endocrine, metabolic, and immune systems throughout the female menstrual cycle. It focuses on how hormonal fluctuations affect glucose metabolism and immune responses, particularly during the luteal phase and menstruation. Participants will undergo an oral glucose tolerance test (oGTT) at various points in their cycle, with blood samples collected to analyze hormonal and metabolic changes. The study aims to clarify the molecular signaling pathways involved and their implications for women's health.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 to 30 with a BMI between 18.5 and 25 and regular menstrual cycles.
Not a fit: Patients with chronic illnesses, mental health issues, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how the menstrual cycle affects metabolic and immune health, potentially leading to better management of related conditions.
How similar studies have performed: While some studies have explored aspects of hormonal influence on metabolism, this comprehensive approach to the menstrual cycle's impact on glucose metabolism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women or men * Age between 20 and 30 years * BMI: 18,5 - 25 kg/m2 * Written informed consent to participate in the study * if applicable: Regular menstruation in the last 6 months * if applicable: Cycle length between 21 and 35 days for each cycle in the last 6 months (self-reported). Exclusion Criteria: * Smoking * Mental illness * Chronic illnesses * Antibiotic therapy 3 weeks before the start of the study * Alcohol, medication and/or drug abuse (BTMG-liable or other psychotropic substances) * Participation in another clinical study at the same time or within the last 30 days * Hospitalization in the last 3 months * Inflammatory condition in the last 30 days or during the course of the study * Other exclusion criteria at the discretion of the physician/investigator * History of infection with SARS-CoV2 before or during the study period * Regular physical activity with very high intensity (athletes) * Coagulation disorders * Planning a restrictive diet for weight loss or medical reasons in the next 3 months * Gastrointestinal disease associated with malabsorption (e.g., Crohn's disease) * Whole blood donation within the last 3 months (women) or last 2 months (men) * Known infertility * Infection with Chlamydia in the past * if applicable: Pregnancy, lactation * if applicable: Use of any contraceptive (hormonal or chemical contraception) within and during the 6 months prior to study entry. An exception are mechanical contraceptives such as condoms * if applicable: planning pregnancy in the next 3 months * if applicable: attempted conception in the past 6 months * if applicable: smear test with abnormal findings in the past 6 months (without subsequent abnormal findings) * if applicable: untreated gynecological infection or of the urogenital tract in the last 6 months * if applicable: gynecological surgery in the last 12 months * if applicable: current or past other gynecologic complaints
Where this trial is running
Bonn
- Rheinische Friedrich-Wilhelms-Universität Bonn — Bonn, Germany (RECRUITING)
Study contacts
- Study coordinator: Marie-Christine Simon, Junior professor
- Email: mcsimon@uni-bonn.de
- Phone: 0228/73-3814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Menstrual Cycle, Immune system & metabolism