Trial Outcomes & Findings for Acute Exercise Effects in Obese Pregnancy (NCT NCT03750695)

Last Updated: 2021-07-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

2 hours post-intervention, up to approximately 3 hours

Results posted on

2021-07-16

Participant Flow

The 3 interventions were: 1) 1-hour of rest, 2) 1-hour of resistance exercise, and 3) 1-hour of aerobic exercise. Each of these interventions were separated by 1-week. N=8 participants were randomized into performing these interventions in the order of rest-aerobic-resistance and n=8 participants in the order of rest-resistance-aerobic.

Participant milestones

Participant milestones
Measure	Rest, Then Aerobic Exercise, and Then Resistance Exercise Order Rest: 40 minutes of quiet rest in semi-recumbent position Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak) Resistance exercise: 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 Participant performed interventions in order of rest, then aerobic exercise, then resistance exercise.	Rest-Resistance-Aerobic Order Rest: 40 minutes of quiet rest in semi-recumbent position Resistance exercise: 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 Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak) Participant performed interventions in order of rest, then resistance exercise, then aerobic exercise.
Overall Study STARTED	8	8
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Rest, Then Aerobic Exercise, and Then Resistance Exercise Order Rest: 40 minutes of quiet rest in semi-recumbent position Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak) Resistance exercise: 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 Participant performed interventions in order of rest, then aerobic exercise, then resistance exercise.	Rest-Resistance-Aerobic Order Rest: 40 minutes of quiet rest in semi-recumbent position Resistance exercise: 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 Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak) Participant performed interventions in order of rest, then resistance exercise, then aerobic exercise.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Acute Exercise Effects in Obese Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=15 Participants Resistance exercise: 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 Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak) Rest: 40 minutes of quiet rest in semi-recumbent position
Age, Continuous	32 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours post-intervention, up to approximately 3 hours

Population: Participants completed all interventions but in different order

Outcome measures

Outcome measures
Measure	Acute Aerobic Exercise n=15 Participants Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)	Acute Resistance Exercise n=15 Participants Resistance exercise: 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 Rest n=15 Participants 1-hour of sitting rest
Oral Glucose Insulin Sensitivity (OGIS) Index	405.0 uU/mL Standard Deviation 56.9	426.0 uU/mL Standard Deviation 53.9	418.9 uU/mL Standard Deviation 67.0

PRIMARY outcome

Timeframe: baseline and immediately post-intervention, approximately 40 minutes

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).

Outcome measures

Outcome measures
Measure	Acute Aerobic Exercise n=15 Participants Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)	Acute Resistance Exercise n=15 Participants Resistance exercise: 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 Rest n=15 Participants 1-hour of sitting rest
Percent Change in Endothelial Function	19.2 percent change Standard Deviation 11.0	20.3 percent change Standard Deviation 8.0	16.1 percent change Standard Deviation 7.7

Adverse Events

Acute Resistance Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acute Aerobic Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acute Resting Session

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William Todd Cade

Duke University

Phone: 919-660-9825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place