NCT02109094|Completed
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Sponsor study identifier
Secondary identifiers
observational
48
1 country
1
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Actual (reported)Study Completion
February 2015
Actual (reported)The investigators seek to examine the metabolic changes that occur amongst obese and lean pregnant women with normal glycemic control as well as pregnant women with diabetes mellitus (gestational diabetes and pre-existing type 2 diabetes mellitus) compared to non-pregnant age matched controls. Given the adaptive tendency of the maternal body to use alternative energy sources such as ketones and free fatty acids rather than glucose and to shunt glucose and amino acids to the fetus, the investigators hypothesize that the amino acid and fatty acid profile will be reflective of this adaptive change and that maternal insulin resistance will result in alterations in this pattern in both the plasma and CSF. Furthermore, the investigators also hypothesize that maternal degrees of insulin resistance will also be reflected in CSF hormonal changes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
April 4, 2014
Actual (reported)April 9, 2014
Actual (reported)February 2015
Actual (reported)February 2015
Actual (reported)Insulin Level (mg/dl)
Baseline (At the time of surgery)
Blood Glucose Level (mmol/L)
Baseline (At the time of surgery)
Plasma Leptin Level
Baseline (At the time of surgery)
All pregnant subjects will be women recruited from the Women's Center, the high-risk prenatal care unit at Tompkins, Long Wharf and L\&D. The target population in this study includes pregnant women with pregnancies complicated by gestational diabetes, DM, and uncomplicated controls. The Yale New Haven Hospital Lumbar puncture clinic, located in the Yale Physicians Building, is a weekly referral clinic in the department of Neurology. The target population for this study includes non-pregnant women, age greater than 18 who require large volume lumbar puncture for medical purposes such as for symptomatic treatment of pseudotumor cerebri.
Yale University
New Haven, Connecticut, United States
whole blood, urine, cerebrospinal fluid, cord blood
Robert Sherwin, MD
Yale University
48 participants (actual enrollment reported by the registry).
First Submitted
April 4, 2014
First Posted
April 9, 2014
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Mobilizing Doulas to Empower Black Women in Post-partum Diabetes Prevention
Medical Nutrition Therapy Program for Pregnant Women With Diabetes
Contact the study team to confirm eligibility.
Primary Completion
February 2015
Actual (reported)Study Completion
February 2015
Actual (reported)Last Updated
March 9, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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