Trial Outcomes & Findings for The Effect of Lactation on Insulin Sensitivity and Lipolysis in Women (NCT NCT04146909)

Last Updated: 2024-02-15

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

2 hours and 4 hours

Results posted on

2024-02-15

Participant Flow

7 participants were screened and consented, 1 participant was screened and consented but did not qualify to be on study, demographics were collected from the 6 qualifying participants, with only 3 of those participants receiving intervention. The study could not be completed as planned due to difficulty to recruit moms during COVID.

Participant milestones

Participant milestones
Measure	Breast Fed and Formula Fed All participants that were breast or formula feeding
Overall Study STARTED	7
Overall Study Screened, Consented and Qualified	6
Overall Study Received Intervention	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Breast Fed and Formula Fed All participants that were breast or formula feeding
Overall Study Withdrawal by Subject	3
Overall Study Did not qualify after consented	1

Baseline Characteristics

The Effect of Lactation on Insulin Sensitivity and Lipolysis in Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breast Feeding n=4 Participants 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. Hyperinsulinemic-euglycemic clamp: 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.	Formula Feeding n=2 Participants 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. Hyperinsulinemic-euglycemic clamp: 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.	Total n=6 Participants Total of all reporting groups
Age, Continuous	36 years STANDARD_DEVIATION 1.5 • n=5 Participants	33 years STANDARD_DEVIATION 1.4 • n=7 Participants	35 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Body Mass Index (BMI)	32 kg/m^2 STANDARD_DEVIATION 7.9 • n=5 Participants	34.8 kg/m^2 STANDARD_DEVIATION 2.5 • n=7 Participants	32.9 kg/m^2 STANDARD_DEVIATION 5.3 • n=5 Participants
Systolic Blood Pressure (BP)	117 mmHg STANDARD_DEVIATION 19 • n=5 Participants	148 mmHg STANDARD_DEVIATION 27 • n=7 Participants	127 mmHg STANDARD_DEVIATION 24 • n=5 Participants
Diastolic BP	78 mmHg STANDARD_DEVIATION 4 • n=5 Participants	81 mmHg STANDARD_DEVIATION 4 • n=7 Participants	79 mmHg STANDARD_DEVIATION 4 • n=5 Participants
Weight	87.8 kg STANDARD_DEVIATION 26.7 • n=5 Participants	88.6 kg STANDARD_DEVIATION 5.7 • n=7 Participants	88.1 kg STANDARD_DEVIATION 17.1 • n=5 Participants
Body Fat percentage	43 percentage of body fat STANDARD_DEVIATION 9.2 • n=5 Participants	46.8 percentage of body fat STANDARD_DEVIATION 3.6 • n=7 Participants	44.2 percentage of body fat STANDARD_DEVIATION 6.4 • n=5 Participants
Fat Mass	45.1 kilograms STANDARD_DEVIATION 11.8 • n=5 Participants	41.5 kilograms STANDARD_DEVIATION 5.9 • n=7 Participants	43.9 kilograms STANDARD_DEVIATION 8.6 • n=5 Participants
Fat Free Mass (FFM)	61.4 kilograms STANDARD_DEVIATION 22.9 • n=5 Participants	47.1 kilograms STANDARD_DEVIATION 0.2 • n=7 Participants	56.6 kilograms STANDARD_DEVIATION 17.4 • n=5 Participants
Cholesterol Total Cholesterol	171.3 mg/dL STANDARD_DEVIATION 18.9 • n=5 Participants	185 mg/dL STANDARD_DEVIATION 49.5 • n=7 Participants	175.8 mg/dL STANDARD_DEVIATION 27 • n=5 Participants
Cholesterol High-Density Lipoprotein (HDL)	55.8 mg/dL STANDARD_DEVIATION 9.9 • n=5 Participants	42 mg/dL STANDARD_DEVIATION 11.3 • n=7 Participants	51.2 mg/dL STANDARD_DEVIATION 11.6 • n=5 Participants
Cholesterol Low-Density Lipoprotein (LDL)	104.3 mg/dL STANDARD_DEVIATION 24.7 • n=5 Participants	124.5 mg/dL STANDARD_DEVIATION 28.9 • n=7 Participants	111 mg/dL STANDARD_DEVIATION 25.3 • n=5 Participants
Cholesterol Triglycerides	57.8 mg/dL STANDARD_DEVIATION 19.2 • n=5 Participants	92.5 mg/dL STANDARD_DEVIATION 46 • n=7 Participants	69.3 mg/dL STANDARD_DEVIATION 31.1 • n=5 Participants
Glucose Levels	66.3 mg/dL STANDARD_DEVIATION 9.5 • n=5 Participants	101.9 mg/dL STANDARD_DEVIATION 28.1 • n=7 Participants	78.1 mg/dL STANDARD_DEVIATION 23.1 • n=5 Participants

PRIMARY outcome

Timeframe: 2 hours and 4 hours

Population: Data presented here is from the 3 participants that came to this appointment.