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Clinical Trials/NCT02109094
NCT02109094
Completed
Not Applicable

Investigating Markers of Energy Metabolism in the CNS and Periphery in Pregnant Women With Varying Degrees of Insulin Resistance

Yale University1 site in 1 country48 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
Yale University
Enrollment
48
Locations
1
Primary Endpoint
Insulin Level (mg/dl)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

We seek to investigate for the first time whether CSF branched chain amino acid, free fatty acid, and energy regulatory hormone levels are altered in comparison to plasma levels among pregnant and non-pregnant individuals with varying degrees of insulin resistance. Furthermore, we seek to understand the effects of pregnancy on central and peripheral energy metabolism using metabolomic profiling as well as traditional hormonal measurements in maternal blood, urine, cerebrospinal fluid as well as cord blood.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
February 2015
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Pregnant women ages 18-45, pre-pregnancy BMI 18-30 with normal glycemic control scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
  • Pregnant women ages 18-45, pre-pregnancy BMI \>30 with normal glycemic control scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
  • Pregnant women ages 18-45 with diabetes (gestational or pre-existing type 2 DM) scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
  • Non-pregnant, non-diabetic women age 18-45 scheduled for lumbar puncture at the Yale-New Haven Hospital Lumbar puncture clinic
  • Able to read and understand English at 6th grade level or higher

Exclusion Criteria

  • Medical disorders other than diabetes. Including psychiatric disorders, alcohol abuse, HIV, hepatitis, renal, hepatic disease, heart disease, active systemic infection, malignancy
  • Pregnancy related medical problems including preeclampsia
  • Major congenital fetal anomalies
  • Smoking and illicit drugs (marijuana, cocaine, benzodiazepines, barbituates)
  • Use of weight loss supplements or dieting 6 months prior to study.
  • Corticosteroid use within 6 months of study.
  • Uncontrolled thyroid disease
  • Medications other than multivitamin, folic acid, or diabetic medications.

Outcomes

Primary Outcomes

Insulin Level (mg/dl)

Time Frame: Baseline (At the time of surgery)

Blood Glucose Level (mmol/L)

Time Frame: Baseline (At the time of surgery)

Plasma Leptin Level

Time Frame: Baseline (At the time of surgery)

Study Sites (1)

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