Investigating Markers of Energy Metabolism in Pregnant Women With Insulin Resistance

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02109094

Enrollment

Registered

2014-04-09

Start date

2014-02-28

Completion date

2015-02-28

Last updated

2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes, Type 2 Diabetes Mellitus

Keywords

insulin, metabolomics

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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)

Countries

United States

Outcome results