Acute Exercise Effects in Obese Pregnancy

NCT03750695 | Completed Results

• 1 other identifier: Pro00105627
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity before and during pregnancy is associated with a higher risk for a number of obstetric and metabolic complications in women and their offspring. Of particular importance, obese women have a higher risk of developing gestational diabetes and preeclampsia. In addition, obese women have larger offspring who have a higher risk for the development of obesity and diabetes; both largely attributed to higher maternal glycemia and glucose intolerance during pregnancy. Thus, identifying rehabilitative interventions that improve maternal and offspring metabolic and cardiovascular health in obese pregnancy are critical and have immediate and generational impact. Resistance and aerobic exercise training is a clinical staple for improving musculoskeletal, metabolic and cardiovascular health in non-gravid adolescents and adults with obesity however little is known regarding the effects of exercise during obese pregnancy. This study proposes to collect preliminary data on the independent effects of acute aerobic and resistance rehabilitative exercise on glucose metabolism and vascular function during pregnancy in n=15 obese women in order to inform a large, multisite clinical trial examining the acute and chronic effects of aerobic and resistance exercise on glucose metabolism and vascular function in normal weight, overweight and obese women during pregnancy.

Conditions

Pregnancy Complications; Obesity; Pre-Eclampsia; Gestational Diabetes

Keywords

exercise; glucose; vascular

Outcome Measures

Primary Outcomes (2)

• Oral Glucose Insulin Sensitivity (OGIS) Index

  Oral Glucose Insulin Sensitivity (OGIS) during a 2-hour oral glucose tolerance test. OGIS (an acronym for Oral Glucose Insulin Sensitivity) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. Mari, et al. OGIS uses modeling of glucose values at 0, 90, 120 min and insulin values at 0 and 90 min (2-h OGTT) to calculate the index. A model-based method for assessing insulin sensitivity from the oral glucose tolerance test. Diabetes Care 2001 Mar;24(3):539-48. The formula for OGIS is the following: (glucose clearance rate + square root(glucose clearance rate\*glucose clearance rate + 4\*pp5\*pp6(glucose at 90 min-gcl)\*330))/2. A calculation spreadsheet for OGIS is found at: http://webmet.pd.cnr.it/ogis/index.php

  2 hours post-intervention, up to approximately 3 hours

• Percent Change in Endothelial Function

  Augmentation index: reactive hyperemic response post-blood pressure cuff inflation. Reactive hyperemia is the transient increase in organ blood flow that occurs following a brief period of ischemia (e.g., arterial occlusion).

  baseline and immediately post-intervention, approximately 40 minutes

Study Arms (3)

Acute Resistance Exercise

EXPERIMENTAL

One acute exercise session of 40 minutes of resistance exercise

Behavioral: Resistance exercise

Acute Aerobic Exercise

EXPERIMENTAL

One acute session of 40 minutes of aerobic exercise

Behavioral: Aerobic Exercise

Acute Resting Session

PLACEBO COMPARATOR

One session of 40 minutes of quiet rest

Behavioral: Rest

Interventions

Resistance exercise BEHAVIORAL

One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise

Acute Resistance Exercise

Aerobic Exercise BEHAVIORAL

One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)

Acute Aerobic Exercise

Rest BEHAVIORAL

40 minutes of quiet rest in semi-recumbent position

Acute Resting Session

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• First trimester BMI ≥ 30.0 and \<45.0 kg/m2 (calculated from clinical weight and height)
• Singleton gestation, between 23 weeks and 0/7 days and 28 weeks and 0/7 days
• Normal fetal anatomy (no major structural abnormalities identified on standard of care survey before enrollment)
• Established prenatal care at Women's Health Clinic before 18 weeks of gestation, plans to deliver at Barnes-Jewish Hospital
• Permission from Obstetrics physician provider to participate in study.

You may not qualify if:

• Gestational or pre-gestational diabetes diagnosis
• Inability to provide voluntary consent
• Currently using illegal drugs (e.g., cocaine, methamphetamine, opiates) (safety risk and potential confounding)
• Current smoker who does not agree to stop (confounding)
• Participation in routine (\>1x/week) exercise program (may improve glucose metabolism/vascular function)
• History of heart disease, orthopedic, metabolic or neurological condition that would contraindicate exercise (safety risk)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Pregnancy Complications; Obesity; Pre-Eclampsia; Diabetes, Gestational; Motor Activity

Interventions

Resistance Training; Exercise; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. William Todd Cade
• Organization: Duke University

todd.cade@duke.edu

919-660-9825

Study Officials

• William Cade, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group crossover design of acute effects of resistance exercise, aerobic exercise or rest (control) on maternal vascular function and glucose metabolism

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 23, 2018
• Study Start: November 20, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: July 16, 2021
• Results First Posted: July 16, 2021

Record last verified: 2021-05

Locations

US (1)