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

Menstrual Cycle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06072391
• Other study ID #: Lfd. Nr. 326/20
• Status: Recruiting
• Start date: November 3, 2021
• Est. completion date: June 15, 2024

Study information

• Verified date: October 2023
• Source: University of Bonn
• Contact: Marie-Christine Simon, Junior professor
• Phone: 0228/73-3814
• Email: mcsimon[@]uni-bonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Within the menstrual cycle there are strong hormonal fluctuations. Therefore, it is obvious that the interaction between the endocrine system and the immune system play an important role in the progression of different diseases during the course of a cycle, especially during the luteal phase and menstruation. The molecular signaling pathways that are active during the menstrual cycle and have an influence on it have not been extensively elucidated to date. Furthermore, glucose homeostasis, on which the female cycle also can have an influence, is part of the research. Study results show that when an oral glucose tolerance test (oGTT) is performed, women are subject to greater fluctuations in blood glucose levels than men. This seems to be dependent on the phases of the female menstrual cycle. It was shown that glucose metabolism was impaired in the luteal phase. Contradictory to this, in another study no significant influence on glucose metabolism by the menstrual cycle could be detected. Based on these equivocal results, in this study the postprandial glucose and insulin response, as well of the glucose-dependent gut hormone GLP-1 in the different cycle phases will be examined. For this purpose, an intervention study is set up in which blood samples are taken at five different time points and the subjects participate in an oGTT at four of these different time points in their individual menstrual cycle. Furthermore, anthropometry measures and body composition will be determined with the help of Bodpod and bioelectrical impedance analysis (BIA) measurements. A diary will also be kept during the entire study duration in order to record the habitual diet. In addition, different subgroups are studied: continuous measurement of body temperature or glucose levels using sensors, continuous collection of stool samples and documentation of daily nutrition using an app. To account for regular daily variations in immunological measurements that are not related to the menstrual cycle, a cohort of healthy, male individuals will be examined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Menstrual Cycle

Locations

Country	Name	City	State
Germany	Rheinische Friedrich-Wilhelms-Universität Bonn	Bonn

Sponsors (3)

Lead Sponsor	Collaborator
University of Bonn	Radboud University Medical Center, University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	characterisation of peripheral immune cells	scRNA-seq, PRECISE platform	through study completion, an average of 1 year
Primary	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
Primary	sex hormones	concentration of estrogen, progesterone, testosterone (pmol/l), central laboratory, UKB Bonn	through study completion, an average of 1 year
Primary	cytokines	concentration of cytokines in blood (pmol/l)	through study completion, an average of 1 year
Secondary	glucose	fasting and postprandial (after OGTT) blood glucose concentration (mg/dl), Biosen C-line, EKF	during the procedure
Secondary	insulin	fasting and postprandial (after OGTT) blood insulin concentration (mU/l), central laboratory, UKB Bonn	through study completion, an average of 1 year
Secondary	gut microbiome	stool: bacterial composition of gut microbiota (diversity, taxonomy)	through study completion, an average of 1 year
Secondary	body height	body height (cm), measured with stadiometer (seca scale 704, seca GmbH und Co. KG, Hamburg)	baseline
Secondary	Habitual diet	Food frequency questionnaire (FFQ), Nutrient (mg/day) and food intake (portions/day)	baseline
Secondary	blood pressure	blood pressure (mmHG) and heart rate (bpm), measured with Boso-carat professional, Bosch und Sohn GmbH und Co. KG, Jungingen)	during the procedure
Secondary	body composition	body composition (fat mass and fat free mass in %), measured with BIA and BOD POD	during the procedure
Secondary	body weight	body weight (kg), measured with electrical scale (seca scale 704, seca GmbH und Co. KG, Hamburg)	during the procedure
Secondary	circumference	circumference of waist and hip (cm), measure tape	during the procedure
Secondary	GLP-1	fasting and postprandial (after OGTT) blood GLP-1 concentration (pmol/l), measured by ELISA	through study completion, an average of 1 year
Secondary	intestinal transit time	intestinal transit time (hours), measured by the "blue-poo" method	baseline
Secondary	stool consistency	questionnaire assessing stool consistency (Bristol-stool-scale), score from 1-7	baseline
Secondary	continuous measurement of body temperature	iButton (Moritz Fuchs Elektronik, Weingarten)	during the procedure
Secondary	continuous measurement of glucose levels	FreeStyle Libre 3 sensor (Abbott GmbH, Wiesbaden)	during the procedure
Secondary	continuous collection of stool samples	continuous measurement of bacterial composition of gut microbiota (diversity, taxonomy)	during the procedure
Secondary	documentation of daily nutrition	Perfood Labs App (Perfood GmbH, Lübeck), macronutrient composition (mg)	during the procedure