Menstrual CycleNCT06072391
Investigating the Endocrine-metabolic-immunological Axis During the Female Menstrual Cycle by Functional Genomics
An observational study of Menstrual Cycle, run by University of Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 3 Nov 2021to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Rheinische Friedrich-Wilhelms-Universität Bonn
Bonn, 53115
Marie-Christine Simon, Junior professor, 0228/73-3814, mcsimon@uni-bonn.de
Tal Pecht, Doctor, 0228 43302 707, talpecht@uni-bonn.de
About this study
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.
Read the detailed 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.
- Conditions
- Menstrual Cycle
- Keywords
- Immune system & metabolism
What is being measured
The primary outcome is the main question the study is designed to answer.
characterisation of peripheral immune cells
scRNA-seq, PRECISE platform
Measured: 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)
Measured: through study completion, an average of 1 year
sex hormones
concentration of estrogen, progesterone, testosterone (pmol/l), central laboratory, UKB Bonn
Measured: through study completion, an average of 1 year
cytokines
concentration of cytokines in blood (pmol/l)
Measured: through study completion, an average of 1 year
Secondary outcomes (16)
glucose
fasting and postprandial (after OGTT) blood glucose concentration (mg/dl), Biosen C-line, EKF
Measured: during the procedure
insulin
fasting and postprandial (after OGTT) blood insulin concentration (mU/l), central laboratory, UKB Bonn
Measured: through study completion, an average of 1 year
gut microbiome
stool: bacterial composition of gut microbiota (diversity, taxonomy)
Measured: through study completion, an average of 1 year
body height
body height (cm), measured with stadiometer (seca scale 704, seca GmbH und Co. KG, Hamburg)
Measured: baseline
Habitual diet
Food frequency questionnaire (FFQ), Nutrient (mg/day) and food intake (portions/day)
Measured: baseline
blood pressure
blood pressure (mmHG) and heart rate (bpm), measured with Boso-carat professional, Bosch und Sohn GmbH und Co. KG, Jungingen)
Measured: during the procedure
body composition
body composition (fat mass and fat free mass in %), measured with BIA and BOD POD
Measured: during the procedure
body weight
body weight (kg), measured with electrical scale (seca scale 704, seca GmbH und Co. KG, Hamburg)
Measured: during the procedure
circumference
circumference of waist and hip (cm), measure tape
Measured: during the procedure
GLP-1
fasting and postprandial (after OGTT) blood GLP-1 concentration (pmol/l), measured by ELISA
Measured: through study completion, an average of 1 year
intestinal transit time
intestinal transit time (hours), measured by the "blue-poo" method
Measured: baseline
stool consistency
questionnaire assessing stool consistency (Bristol-stool-scale), score from 1-7
Measured: baseline
continuous measurement of body temperature
iButton (Moritz Fuchs Elektronik, Weingarten)
Measured: during the procedure
continuous measurement of glucose levels
FreeStyle Libre 3 sensor (Abbott GmbH, Wiesbaden)
Measured: during the procedure
continuous collection of stool samples
continuous measurement of bacterial composition of gut microbiota (diversity, taxonomy)
Measured: during the procedure
documentation of daily nutrition
Perfood Labs App (Perfood GmbH, Lübeck), macronutrient composition (mg)
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start3 Nov 2021
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bonn, Radboud University Medical Center
- Responsible party
- Principal investigator, Marie-Christine Simon, PhD MSc RD, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072391
- Sponsor's protocol ID
- Lfd. Nr. 326/20
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Endocrine-metabolic-immunological Axis During the Female Menstrual Cycle by Functional Genomics
- ClinicalTrials.gov ID
- NCT06072391
- Acronym / sponsor ID
- Lfd. Nr. 326/20
- Conditions
- Menstrual Cycle
- Keywords
- Immune system & metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Collaborators
- University Hospital, Bonn, Radboud University Medical Center
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
characterisation of peripheral immune cells
Time frame: through study completion, an average of 1 year
scRNA-seq, PRECISE platform
gonadotropins
Time frame: through study completion, an average of 1 year
concentration of luteinizing hormone (LH), follicle stimulating hormone (FSH) (pmol/l), central laboratory, University Hospital Bonn (UKB)
sex hormones
Time frame: through study completion, an average of 1 year
concentration of estrogen, progesterone, testosterone (pmol/l), central laboratory, UKB Bonn
cytokines
Time frame: through study completion, an average of 1 year
concentration of cytokines in blood (pmol/l)
16 secondary outcomes
glucose
Time frame: during the procedure
insulin
Time frame: through study completion, an average of 1 year
gut microbiome
Time frame: through study completion, an average of 1 year
body height
Time frame: baseline
Habitual diet
Time frame: baseline
blood pressure
Time frame: during the procedure
body composition
Time frame: during the procedure
body weight
Time frame: during the procedure
circumference
Time frame: during the procedure
GLP-1
Time frame: through study completion, an average of 1 year
intestinal transit time
Time frame: baseline
stool consistency
Time frame: baseline
continuous measurement of body temperature
Time frame: during the procedure
continuous measurement of glucose levels
Time frame: during the procedure
continuous collection of stool samples
Time frame: during the procedure
documentation of daily nutrition
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Menstrual Cycle
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
RecruitingObservational study
Body Clocks - Coordination of Peripheral and Central Oscillators
Circadian Dysregulation
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Heavy Menstrual Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Christine Simon, Junior professor (0228/73-3814, mcsimon@uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterisation of peripheral immune cells (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.