Investigating the Endocrine-metabolic-immunological Axis During the Female Menstrual Cycle by Functional Genomics

NCT06072391 | Unknown

• 1 other identifier: Lfd. Nr. 326/20
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

As there are fluctuations in the hormonal balance during the menstrual cycle, it is assumed that due to the interaction between the hormonal system and the immune system, some diseases might be worsened in the course of a cycle. This interaction is particularly important during the phases of the cycle when the corpus luteum is formed and secretes estrogens and progesterone (secretion phase, luteal phase), as well as during menstruation itself. To date, there is no comprehensive review regarding the molecular signaling pathways that are active during and influence the menstrual cycle. The menstrual cycle influences blood glucose levels. Women are subject to greater fluctuations in blood glucose levels than men according to the phases of the menstrual cycle (menstrual phase, proliferative phase, ovulation, luteal phase). Since there are contradictory results regarding the influence of the menstrual cycle on glucose metabolism, the glucose and insulin response, as well as the glucose-dependent intestinal hormone glucagon-like peptide 1(GLP-1) after food intake are determined in the study presented here using an oral glucose tolerance test.

Conditions

Menstrual Cycle

Keywords

Immune system & metabolism

Outcome Measures

Primary Outcomes (4)

• characterisation of peripheral immune cells

  scRNA-seq, PRECISE platform

  through study completion, an average of 1 year

• gonadotropins

  concentration of luteinizing hormone (LH), follicle stimulating hormone (FSH) (pmol/l), central laboratory, University Hospital Bonn (UKB)

  through study completion, an average of 1 year

• sex hormones

  concentration of estrogen, progesterone, testosterone (pmol/l), central laboratory, UKB Bonn

  through study completion, an average of 1 year

• cytokines

  concentration of cytokines in blood (pmol/l)

  through study completion, an average of 1 year

Secondary Outcomes (16)

• glucose

  during the procedure

• insulin

  through study completion, an average of 1 year

• gut microbiome

  through study completion, an average of 1 year

• body height

  baseline

• Habitual diet

  baseline

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study participants are healthy young women with a regular menstrual cycle or heathy young men aged 20-30 years. The subjects are predominantly female students at the University of Bonn.

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Bonn: lead
• University Hospital, Bonn: collaborator
• Radboud University Medical Center: collaborator

Study Sites (1)

Rheinische Friedrich-Wilhelms-Universität Bonn

Bonn, 53115, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

frozen EDTA and plasma samples frozen stool samples for microbial DNA extraction

Central Study Contacts

Marie-Christine Simon, Junior professor

CONTACT

0228/73-3814; mcsimon@uni-bonn.de

Tal Pecht, Doctor

CONTACT

0228 43302 707; talpecht@uni-bonn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jun. Prof. Dr. Marie-Christine Simon

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 10, 2023
• Study Start: November 3, 2021
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

DE (1)