Understanding how breast stimulation affects prolactin levels in non-lactating women
Prolactin Release Through Breast Stimulation in Non-lactating Women - Who Does Respond?
This study tests how breast stimulation affects hormone levels in young, healthy women who aren't breastfeeding to see if it influences their metabolism and insulin sensitivity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT05208684 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of breast stimulation on prolactin release in young, healthy, non-lactating women. By inducing a temporary increase in prolactin levels without pharmacological intervention, the study aims to explore the hormone's acute metabolic effects, particularly its influence on glucose metabolism and insulin sensitivity. Participants will be closely monitored to assess how these changes may relate to metabolic processes. The findings could provide insights into the role of prolactin beyond reproduction and lactation.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 18 to 45 with a BMI under 25 who are not pregnant or breastfeeding.
Not a fit: Patients with diabetes, serious illnesses, or those who have undergone certain breast surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of prolactin's role in metabolic health, potentially leading to new strategies for managing insulin sensitivity.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated a link between prolactin levels and metabolic processes, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women, aged between 18 and 45 years * premenopausal (women, who had menses at any time in the preceding 24 consecutive months) * BMI \< 25 kg/m² * Ability to understand and voluntarily sign an informed consent document prior to any study related procedures Exclusion Criteria: * Type 1 or Type 2 diabetes * Intake of medication which may affect prolactin levels (e.g. Metoclopramide, Methyldopa, opiates, cimetidine), except birth control pill/hormonal contraception known hyperprolactinemia or hyperthyroidism * any other serious illness that might impact the results as judged by the investigator (e.g. malignant disease, coronary heart disease) * Pregnant / breastfeeding women (weaning at least 6 month ago) * plastic breast surgery (with detachment of milk ducts) * allergy to BPA-free plastic
Where this trial is running
Tübingen
- University Hospital Tuebingen, Otfried-Mueller Str. 10 — Tübingen, Germany (Recruiting)
Study contacts
- Study coordinator: Louise Fritsche, Dr.rer.nat.
- Email: louise.fritsche@med.uni-tuebingen.de
- Phone: +4970712780687
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.