The Effect of Lactation on Insulin Sensitivity and Lipolysis in Women (NCT04146909) | Clinical Trial Compass
TerminatedNot Applicable
The Effect of Lactation on Insulin Sensitivity and Lipolysis in Women
Stopped: The study could not be completed as planned due to difficulty to recruit moms during COVID.
United States7 participantsStarted 2020-11-17
Plain-language summary
This purpose of this study is to investigate whether lactation improves insulin sensitivity and increases lipolysis in women.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A history of GDM (as defined as the American Diabetes Association criteria)
* Delivered a singleton, live birth at ≥ 35 weeks gestation within the past 18 months
* HbA1C \< 6.5% at time of screening
* Delivery within the past 18 months
* Breast Feed Group: exclusively or mostly breast-fed (\< 6 ounces of formula/24 hours at 6-9 weeks of delivery) for at least 4-6 months
Exclusion Criteria:
* Currently lactating or lactation within the past 1 month at the time of the screening visit
* Diagnosis of diabetes (T1D or T2D) prior to pregnancy
* Current use of any glucose-lowering agents
* Pregnancy related medical problems including preeclampsia
* Major congenital fetal anomalies
* Creatinine \> 1.5mg/dL, Hematocrit \< 35%, ALT and AST \> 2.5X upper limit of normal
* Known psychiatric disorders, alcohol abuse, HIV, hepatitis, renal disease, hepatic disease, untreated heart disease, untreated thyroid disease, active systemic infection or malignancy
* Illicit drug use (by the participant's self-report)
* History of post-partum depression
* Use of weight loss supplements or dieting 6 months prior to study
* Corticosteroid or opiate use within 6 months of study
What they're measuring
1
Whole Body Insulin Sensitivity Measured by the Glucose Infusion Rate