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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.
Maternal obesity prevalence is at a historic high with over 1 in 3 women entering pregnancy obese and 1 in 10 extremely obese. 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. Observational studies suggest that exercise in pregnancy is safe and higher levels of physical activity before and during pregnancy in normal weight (i.e. lean) women reduces the risk of gestational diabetes and gestational hypertensive disorders; however, little is known regarding the effects of exercise training during obese pregnancy and several important questions still exist. These include: 1) "What are the acute and chronic effects of maternal exercise on glucose metabolism and vascular function?", 2) "Are there different effects of aerobic and resistance type exercise on glucose metabolism and vascular function?" and 3) "What are the physiologic and molecular transducers of maternal aerobic and resistance exercise for changes in maternal glucose metabolism and vascular function during pregnancy?" This pilot project aims to collect preliminary data on these questions.
This proposal would be the first study to collect preliminary data on the independent effects of acute aerobic and resistance rehabilitative exercise in pregnancy, and further, in obese women; a population with a high morbidity during gestation. In addition, this proposal would 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. Moreover, this proposal would provide initial evidence of molecular transducers of acute physical activity/rehabilitative exercise necessary for a large, comprehensive clinical trial examining the molecular transducers of rehabilitative exercise in normal weight, overweight and obese women during different stages of pregnancy.
Specific Aim #1: To characterize the acute effects of aerobic and resistance exercise on glucose metabolism (tolerance, insulin sensitivity and β-cell function) in obese women during mid-pregnancy.
Specific Aim #2: To characterize the acute effects of aerobic and resistance exercise on vascular function in obese women during mid-pregnancy.
Specific Aim #3: To explore the molecular transducers of physiologic responses in glucose metabolism and vascular function following acute aerobic and resistance exercise in obese women during mid-pregnancy.
The hypothesis is that acute aerobic and resistance rehabilitative exercise will improve post-exercise glucose metabolism and vascular function in obese women during mid-pregnancy. In a subsequent multi-site clinical trial, this study will examine differences in physiologic effects and molecular transducers of aerobic and resistance exercise on glucose metabolism and vascular function during different stages of pregnancy in overweight and obese women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Resistance Exercise | Experimental | One acute exercise session of 40 minutes of resistance exercise |
|
| Acute Aerobic Exercise | Experimental | One acute session of 40 minutes of aerobic exercise |
|
| Acute Resting Session | Placebo Comparator | One session of 40 minutes of quiet rest |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Cade, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the study. All participants were randomized to receive all interventions.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Participants completed all interventions but in different order | Posted | Mean | Standard Deviation | uU/mL | 2 hours post-intervention, up to approximately 3 hours |
|
Approximately 3 hours after each intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acute Resistance Exercise | One acute exercise session of 40 minutes of resistance exercise 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Todd Cade | Duke University | 919-660-9825 | todd.cade@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2018 | Mar 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D009765 | Obesity |
| D011225 | Pre-Eclampsia |
| D016640 | Diabetes, Gestational |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D015444 | Exercise |
| C092779 | RE1-silencing transcription factor |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Single group crossover design of acute effects of resistance exercise, aerobic exercise or rest (control) on maternal vascular function and glucose metabolism
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| Aerobic Exercise | Behavioral | One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak) |
|
| Rest | Behavioral | 40 minutes of quiet rest in semi-recumbent position |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 |
| Acute Aerobic Exercise |
Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak) |
| OG001 | Acute Resistance Exercise | 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 |
| OG002 | Acute Rest | 1-hour of sitting rest |
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | percent change | baseline and immediately post-intervention, approximately 40 minutes |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Acute Aerobic Exercise | One acute session of 40 minutes of aerobic exercise Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak) | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Acute Resting Session | One session of 40 minutes of quiet rest Rest: 40 minutes of quiet rest in semi-recumbent position | 0 | 16 | 0 | 16 | 0 | 16 |
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| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046110 | Hypertension, Pregnancy-Induced |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |