The Effect of Lactation on Insulin Sensitivity and Lipolysis in Women

NCT04146909 | Terminated Results DMC

• 2 other identifiers: 20000257311R21HD100751-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This purpose of this study is to investigate whether lactation improves insulin sensitivity and increases lipolysis in women.

Conditions

GDM; Lactation

Outcome Measures

Primary Outcomes (3)

• Whole Body Insulin Sensitivity Measured by the Glucose Infusion Rate

  The glucose infusion rate is determined by the amount of 20% dextrose given during the hyperinsulinemic-euglycemic clamp study, necessary to keep blood glucose levels at the target range (90-100 mg/dL). Higher rates of infused dextrose indicates greater sensitivity to infused insulin during the hyperinsulinemic-euglycemic clamp. Women with gestational diabetes are expected to be insulin resistant.

  2 hours and 4 hours

• Endogenous Glucose Production

  Determined with \[6,6-2H\] Glucose tracer given during the hyperinsulinemic-euglycemic clamp study. Lower values of endogenous glucose production indicates greater hepatic insulin sensitivity.

  4 hours

• Whole Body Lipid Turnover Rates

  Determined with \[2H5\] Glycerol tracer given during the hyperinsulinemic-euglycemic clamp study. Tracer levels in the plasma determinates how the body uses fat in the blood during the hyperinsulinemic-euglycemic clamp study.

  4 hours

Secondary Outcomes (3)

• Plasma NEFA

  4 hours

• Triglycerides

  4 hours

• Insulin Levels

  4 hours

Study Arms (2)

Breast Feeding

ACTIVE COMPARATOR

This group will consist of women who exclusively or mostly breast-fed for at least 4-6 months (\< 6 ounces of formula/24 hours at 6-9 weeks of delivery)1 and who delivered within the past 18 months.

Diagnostic Test: Hyperinsulinemic-euglycemic clamp

Formula Feeding

ACTIVE COMPARATOR

This group will consist of women who exclusively or mostly formula-fed (no breastfeeding or \< 3 weeks of breastfeeding)1 and who delivered within the past 18 months.

Diagnostic Test: Hyperinsulinemic-euglycemic clamp

Interventions

Hyperinsulinemic-euglycemic clamp DIAGNOSTIC_TEST

After an overnight fast and an equilibration period lasting 2 hours, the 2-step euglycemic-hyperinsulinemic clamp study will be performed. A primed-continuous infusion of regular insulin will be given at 8 mU/(m2 × min) during the first 2 hours, and increased to 40 mU/(m2 × min) for the subsequent 2 hours. Plasma glucose levels will be measured every 5 min, and a variable glucose infusion will be initiated to maintain levels at ∼90 mg/dl. Plasma samples will be drawn at baseline and throughout the infusion period for measurement of isotope enrichment, insulin, NEFA, glycerol turnover, and additional hormones which may be altered with lactation. Approximately 160 mL of blood will be drawn at this visit.

Breast Feeding; Formula Feeding

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Results Point of Contact

• Title: Renata Belfort De Aguiar, MD, PhD
• Organization: Yale School of Medicine

renata.aguiar@yale.edu

(203) 785-5331

Study Officials

• Renate Belfort De Aguiar, MD, PhD

  Assistant Professor of Medicine (Endocrinology)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: November 17, 2020
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: February 15, 2024
• Results First Posted: December 20, 2023

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)