Postmenopausal SymptomsNCT05351476
Exercise Training and Fat Metabolism in Postmenopausal Women
A study testing Resistance Exercise and Endurance Exercise in people with Postmenopausal Symptoms and Obesity, run by Florida State University at 1 site in United States.
Trial summary
Adipose tissue turnover plays a critical role in body weight maintenance, and obesity is underscored by the dysregulated balance between fat breakdown and synthesis. Although there are clear health-related benefits of physical activity, little is known about how resistance exercise, as opposed to endurance exercise… Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Postmenopausal Symptoms, Obesity, Prediabetic State
- What is being tested?
- Resistance Exercise and Endurance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2022to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Postmenopausal (50-75 yrs.)
- Obese (BMI 30-50 kg/m2)
- Prediabetes (HbA1c 5.7 - 6.4% or fasting blood glucose 100 to 125 mg/dL, or 2hr OGTT blood glucose 140 to 199 mg/dL)
- Sedentary (not performing purposeful exercise training more than 20 minutes per day twice a week)
- Non-smokers
- No hormone replacement therapy for at least the past two years.
Who cannot join
- Engaging in purposeful resistance training or endurance training (> 20min/day, > 2 days/week)
- Resting blood pressure above 140 mmHg systolic or 90 mmHg diastolic
- Type 1 or type 2 diabetes
- Medical problems in which exercise is contraindicated, such as chronic infections
- History of, or currently presentation with, cancer, cardiovascular or respiratory disease
- Uncontrolled thyroid dysfunction, liver or renal dysfunction
Show all 9Show fewer
- Taking any medication affecting lipid metabolism
- Musculoskeletal disease or injury that would otherwise prevent engagement in resistance and endurance training
- Smokers and those with diagnosed eating disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida State University
Tallahassee, Florida, 32306
Michael J Ormsbee, PhD
About this study
Official title: Resistance Training Modulation of Fat Metabolism in Obese Postmenopausal Women
Adipose tissue turnover plays a critical role in body weight maintenance, and obesity is underscored by the dysregulated balance between fat breakdown and synthesis. Although there are clear health-related benefits of physical activity, little is known about how resistance exercise, as opposed to endurance exercise, can reduce the risk of metabolic disorders, particularly in women. The goal of the proposed study is to investigate the effectiveness of resistance training to improve basal and stimulated fat metabolism in postmenopausal women with obesity and pre-diabetes, potentially serving as a viable and practical approach to prevent the onset of type 2 diabetes.
Read the detailed description
The primary objective is to compare the effects of 12 weeks of resistance training to endurance training with respect to whole-body and regional lipolytic (fat breakdown) responses to acute walking exercise, (Aim 1), local adrenergic receptor blockade (Aim 2) and in response to insulin during a hyperinsulinemic-euglycemic clamp (Aim 3). The investigators will study the lipolytic response in the context of acute exercise, whole-body fat oxidation and resting energy expenditure data. The investigators will collect data on chronic lipogenesis (fat synthesis) and adipogenesis (fat cell formation), as well as on ambulatory blood glucose control. Microdialysis techniques will be utilized to determine the lipolytic rate in subcutaneous abdominal and gluteal adipose tissue at rest, as well as during and after physical activity (walking) or during a hyperinsulinemiceuglycemic clamp (including thigh muscle), before and after 12 weeks of either resistance training or endurance training. To investigate the adrenergic regulation of lipolysis before, during, and after exercise, a saline/ ethanol solution will be perfused (to monitor blood flow) through three separate microdialysis probes in subcutaneous abdominal and gluteal adipose tissue. The perfusate in the probes will consist of either: 1) no additional substances (control probe) to address Aim 1; or 2) phentolamine, an alpha adrenoreceptor blocker (treatment probe), and 3) propranolol, a beta adrenoreceptor blocker (second treatment probe) to address Aim 2. Hyperinsulinemic-euglycemic clamps will be performed to study the whole-body (with stable isotope tracers) and regional (with microdialysis) antilipolytic effect of insulin, as well as to measure insulin sensitivity with respect to glucose metabolism, before and after the training programs for Aim 3. Immediately following the controlled laboratory experiments, glycerol profiles (index of lipolysis) and glucose profiles (index of glucose control) will continue to be monitored in the participant's free-living environment over the ensuing 18 hours until the following morning. Additionally, at weeks 4 and 12 participants will come to the lab for adipose tissue biopsies of the abdominal and gluteal adipose tissue for determination of adipogenesis and lipogenesis using stable-isotope-labeled water they will drink daily over this eight-week labeling period. Additional measures of fat oxidation as well as chronic and acute fat deposition will allow interpretation of lipolysis in the context of fat oxidation and fat accumulation, while 24-hour lipolysis and glucose profile measures will allow investigation of fat metabolism and glucose control in a free-living condition. These studies will provide a greater understanding of how these exercise modalities affect metabolism in women with obesity and prediabetes, allowing practitioners to make more evidence based exercise prescriptions intended to improve body composition, glycemic control, and weight management.
The sample size for these studies will consist of 120 participants that will be randomly assigned via computer randomization to either resistance training (n=60) or endurance training (n=60) for 12 weeks. This sample size gives sufficient statistical power to detect differences in lipolytic rate and other outcome variables, as determined by previous studies examining similar outcome measures. A combination of stable tracers will be infused into the bloodstream to examine various measures of fat metabolism under resting and exercise conditions, as well as during a procedure that mimics a meal (hyperinsulinemic-euglycemic clamp). However, these various tracers can interfere with each other if studied altogether. Therefore these respective isotope tracer measures will be run in only one-half of the participants from each Aim. 30 participants in the endurance training group and 30 participants in the resistance training group will complete Aims 1 and 2. A different 30 participants in the endurance training group and 30 in the resistance training group will complete Aim 3. Among the 60 participants (30 from each exercise training group) completing Aims 1 and 2, there will be 15 individuals from each exercise training group who will be randomized to undergo the tracer measures during exercise while the other 15 from each exercise training group addressing Aims 1 and 2 will complete the exercise protocol without the tracer methods. These randomization methods will also be applied to the 60 participants completing Aim 3, although these participants will undergo a hyperinsulinemic-euglycemic clamp with or without the tracer methods.
Participants will be recruited, screened, enrolled, and tested during months 4-55 of this grant. Participant recruitment procedures and procurement of needed supplies will occur during the first 3 months of the project. Additional recruitment, as well as screening and testing of participants will occur at 1-2 per month over the ensuing 52 months. Two microdialysis experiments will be performed on participants, one before and one after 12 weeks of exercise training, for a total of 240 microdialysis experiments. This plan will therefore require 4-5 microdialysis tests per month on average during the testing months. Stable label palmitate and glycerol isotope experiments will be conducted in 30 of the 60 participants undergoing the acute walking microdialysis experiments and in 30 of the 60 participants undergoing the clamp experiment. Deuterium water isotope experiments (studies of lipogenesis and adipogenesis) will be conducted in 60 of the participants.
- Conditions
- Postmenopausal Symptoms, Obesity, Prediabetic State
- Being tested
- Resistance Exercise, Endurance Exercise
- Keywords
- Resistance Exercise, Fat Metabolism, Postmenopause
- Medical subject headings
- Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
Also called Weight Lifting
200 Kcal worth of weightlifting, 3 times/week for 12 weeks
Endurance ExerciseBehavioural
Also called Aerobic Exercise
200 Kcal worth of treadmill walking, 3 times/week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise | Experimental | Participants do regular resistance exercise for 12 weeks. Receives: Behavioral: Resistance Exercise |
| Endurance Exercise | Experimental | Participants do regular endurance exercise for 12 weeks. Receives: Behavioral: Endurance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline subcutaneous abdominal adipose tissue glycerol concentration at 12 weeks
Changes in physical activity (walking)-stimulated lipolysis will be assessed as measured by glycerol concentration in dialysate samples from subcutaneous abdominal adipose tissue utilizing a powerful in-vivo microdialysis methodology
Measured: 12 weeks of resistance or endurance training
Change from baseline gluteal adipose tissue glycerol concentration at 12 weeks
Changes in physical activity (walking)-stimulated lipolysis will be assessed as measured by glycerol concentration in dialysate samples from gluteal adipose tissue utilizing a powerful in-vivo microdialysis methodology
Measured: 12 weeks of resistance or endurance training
Change from baseline whole-body lipolysis at 12 weeks
Whole body lipolysis will be measured using whole body rate of appearance of 2H5-glycerol in blood samples collected at rest, during walking exercise, and for 120 minutes after exercise.
Measured: 12 weeks of resistance or endurance training
Secondary outcomes (7)
Change in blood flow as measured by ethanol concentrations in dialysate samples from subcutaneous abdominal adipose tissue
Ethanol (~10 mM) will be included with the perfusion medium through the microdialysis probe. Blood flow will be expressed as a ratio of the ethanol concentration in the dialysate (outflow) and the ethanol concentration in the perfusate (inflow)
Measured: 12 weeks of resistance or endurance training
Change in dialysate ethanol data in subcutaneous gluteal adipose tissue
Ethanol (~10 mM) will be included with the perfusion medium through the microdialysis probe. Blood flow will be expressed as a ratio of the ethanol concentration in the dialysate (outflow) and the ethanol concentration in the perfusate (inflow)
Measured: 12 weeks of resistance or endurance training
Change in the ratio of 13CO2 to 12CO2 in breath samples
This measure will allow for the calculation of whole-body fat oxidation under conditions of rest, walking exercise, and hyperinsulinemiceuglycemic clamp.
Measured: 12 weeks of resistance or endurance training
change in body composition
Body composition (body mass, lean mass, fat mass, visceral fat) will be measured before and after 12 weeks of resistance or endurance training.
Measured: 12 weeks of resistance or endurance training
Change in blood growth hormone concentrations
Concentrations of growth hormone in plasma samples will be measured before and after 12 weeks of resistance or endurance training.
Measured: 12 weeks of resistance or endurance training
Change in lipogenesis
Fat synthesis will be assessed in fat biopsies from subcutaneous abdominal and gluteal adipose tissue using deuterium labeled fatty acids following deuterated water administration in the free-living setting.
Measured: 12 weeks of resistance or endurance training
Change in adipogenesis
New fat cell formation/proliferation will be assessed in fat biopsies from subcutaneous abdominal and gluteal adipose tissue via adipocytes and preadipocytes DNA quantification using deuterated water in the free-living setting.
Measured: 12 weeks of resistance or endurance training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start20 May 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal SymptomsStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Pennington Biomedical Research Center, University of Arkansas
- Responsible party
- Principal investigator, Michael J. Ormsbee, Florida State University
- Investigators
- Robert C Hickner, PhD, Principal investigator, Florida State UniversityMichael J Ormsbee, PhD, Principal investigator, Florida State UniversityMostafa M Ali, PhD, Study director, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351476
- Sponsor's protocol ID
- STUDY00001939
- Other IDs
- R01DK125728
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bonafiglia JT, Rotundo MP, Whittall JP, Scribbans TD, Graham RB, Gurd BJ. Inter-Individual Variability in the Adaptive Responses to Endurance and Sprint Interval Training: A Randomized Crossover Study. PLoS One. 2016 Dec 9;11(12):e0167790. doi: 10.1371/journal.pone.0167790. eCollection 2016.
PubMed 27936084Kim J, Wang Z, Heymsfield SB, Baumgartner RN, Gallagher D. Total-body skeletal muscle mass: estimation by a new dual-energy X-ray absorptiometry method. Am J Clin Nutr. 2002 Aug;76(2):378-83. doi: 10.1093/ajcn/76.2.378.
PubMed 12145010Hopkins WG. Measures of reliability in sports medicine and science. Sports Med. 2000 Jul;30(1):1-15. doi: 10.2165/00007256-200030010-00001.
PubMed 10907753Culver AL, Ockene IS, Balasubramanian R, Olendzki BC, Sepavich DM, Wactawski-Wende J, Manson JE, Qiao Y, Liu S, Merriam PA, Rahilly-Tierny C, Thomas F, Berger JS, Ockene JK, Curb JD, Ma Y. Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative. Arch Intern Med. 2012 Jan 23;172(2):144-52. doi: 10.1001/archinternmed.2011.625. Epub 2012 Jan 9.
PubMed 22231607Kim JY, Hickner RC, Cortright RL, Dohm GL, Houmard JA. Lipid oxidation is reduced in obese human skeletal muscle. Am J Physiol Endocrinol Metab. 2000 Nov;279(5):E1039-44. doi: 10.1152/ajpendo.2000.279.5.E1039.
PubMed 11052958Hickner RC, Racette SB, Binder EF, Fisher JS, Kohrt WM. Suppression of whole body and regional lipolysis by insulin: effects of obesity and exercise. J Clin Endocrinol Metab. 1999 Nov;84(11):3886-95. doi: 10.1210/jcem.84.11.6137.
PubMed 10566624Hickner RC, Racette SB, Binder EF, Fisher JS, Kohrt WM. Effects of 10 days of endurance exercise training on the suppression of whole body and regional lipolysis by insulin. J Clin Endocrinol Metab. 2000 Apr;85(4):1498-504. doi: 10.1210/jcem.85.4.6550.
PubMed 10770188Sial S, Coggan AR, Hickner RC, Klein S. Training-induced alterations in fat and carbohydrate metabolism during exercise in elderly subjects. Am J Physiol. 1998 May;274(5):E785-90. doi: 10.1152/ajpendo.1998.274.5.E785.
PubMed 9612234Hickner RC, Rosdahl H, Borg I, Ungerstedt U, Jorfeldt L, Henriksson J. The ethanol technique of monitoring local blood flow changes in rat skeletal muscle: implications for microdialysis. Acta Physiol Scand. 1992 Sep;146(1):87-97. doi: 10.1111/j.1748-1716.1992.tb09396.x.
PubMed 1442130Pierce JR, Maples JM, Hickner RC. IL-15 concentrations in skeletal muscle and subcutaneous adipose tissue in lean and obese humans: local effects of IL-15 on adipose tissue lipolysis. Am J Physiol Endocrinol Metab. 2015 Jun 15;308(12):E1131-9. doi: 10.1152/ajpendo.00575.2014. Epub 2015 Apr 28.
PubMed 25921578Gavin KM, Cooper EE, Raymer DK, Hickner RC. Estradiol effects on subcutaneous adipose tissue lipolysis in premenopausal women are adipose tissue depot specific and treatment dependent. Am J Physiol Endocrinol Metab. 2013 Jun 1;304(11):E1167-74. doi: 10.1152/ajpendo.00023.2013. Epub 2013 Mar 26.
PubMed 23531620Ormsbee MJ, Choi MD, Medlin JK, Geyer GH, Trantham LH, Dubis GS, Hickner RC. Regulation of fat metabolism during resistance exercise in sedentary lean and obese men. J Appl Physiol (1985). 2009 May;106(5):1529-37. doi: 10.1152/japplphysiol.91485.2008. Epub 2009 Mar 5.
PubMed 19265063Ormsbee MJ, Clapper JA, Clapper JL, Vukovich MD. The impact of varying dietary protein on serum IGF-I, IGFBP-1, and IGFBP-3 during 6 days of physical activity. Int J Sport Nutr Exerc Metab. 2007 Apr;17(2):127-39. doi: 10.1123/ijsnem.17.2.127.
PubMed 17507738
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training Modulation of Fat Metabolism in Obese Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05351476
- Acronym / sponsor ID
- STUDY00001939
- Conditions
- Postmenopausal Symptoms, Obesity, Prediabetic State
- Keywords
- Resistance Exercise, Fat Metabolism, Postmenopause
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Pennington Biomedical Research Center, University of Arkansas
- Study start
- 20 May 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adipose tissue turnover plays a critical role in body weight maintenance, and obesity is underscored by the dysregulated balance between fat breakdown and synthesis. Although there are clear health-related benefits of physical activity, little is known about how resistance exercise, as opposed to endurance exercise, can reduce the risk of metabolic disorders, particularly in women. The goal of the proposed study is to investigate the effectiveness of resistance training to improve basal and stimulated fat metabolism in postmenopausal women with obesity and pre-diabetes, potentially serving as a viable and practical approach to prevent the onset of type 2 diabetes.
Detailed description
The primary objective is to compare the effects of 12 weeks of resistance training to endurance training with respect to whole-body and regional lipolytic (fat breakdown) responses to acute walking exercise, (Aim 1), local adrenergic receptor blockade (Aim 2) and in response to insulin during a hyperinsulinemic-euglycemic clamp (Aim 3). The investigators will study the lipolytic response in the context of acute exercise, whole-body fat oxidation and resting energy expenditure data. The investigators will collect data on chronic lipogenesis (fat synthesis) and adipogenesis (fat cell formation), as well as on ambulatory blood glucose control. Microdialysis techniques will be utilized to determine the lipolytic rate in subcutaneous abdominal and gluteal adipose tissue at rest, as well as during and after physical activity (walking) or during a hyperinsulinemiceuglycemic clamp (including thigh muscle), before and after 12 weeks of either resistance training or endurance training. To investigate the adrenergic regulation of lipolysis before, during, and after exercise, a saline/ ethanol solution will be perfused (to monitor blood flow) through three separate microdialysis probes in subcutaneous abdominal and gluteal adipose tissue. The perfusate in the probes will consist of either: 1) no additional substances (control probe) to address Aim 1; or 2) phentolamine, an alpha adrenoreceptor blocker (treatment probe), and 3) propranolol, a beta adrenoreceptor blocker (second treatment probe) to address Aim 2. Hyperinsulinemic-euglycemic clamps will be performed to study the whole-body (with stable isotope tracers) and regional (with microdialysis) antilipolytic effect of insulin, as well as to measure insulin sensitivity with respect to glucose metabolism, before and after the training programs for Aim 3. Immediately following the controlled laboratory experiments, glycerol profiles (index of lipolysis) and glucose profiles (index of glucose control) will continue to be monitored in the participant's free-living environment over the ensuing 18 hours until the following morning. Additionally, at weeks 4 and 12 participants will come to the lab for adipose tissue biopsies of the abdominal and gluteal adipose tissue for determination of adipogenesis and lipogenesis using stable-isotope-labeled water they will drink daily over this eight-week labeling period. Additional measures of fat oxidation as well as chronic and acute fat deposition will allow interpretation of lipolysis in the context of fat oxidation and fat accumulation, while 24-hour lipolysis and glucose profile measures will allow investigation of fat metabolism and glucose control in a free-living condition. These studies will provide a greater understanding of how these exercise modalities affect metabolism in women with obesity and prediabetes, allowing practitioners to make more evidence based exercise prescriptions intended to improve body composition, glycemic control, and weight management.
The sample size for these studies will consist of 120 participants that will be randomly assigned via computer randomization to either resistance training (n=60) or endurance training (n=60) for 12 weeks. This sample size gives sufficient statistical power to detect differences in lipolytic rate and other outcome variables, as determined by previous studies examining similar outcome measures. A combination of stable tracers will be infused into the bloodstream to examine various measures of fat metabolism under resting and exercise conditions, as well as during a procedure that mimics a meal (hyperinsulinemic-euglycemic clamp). However, these various tracers can interfere with each other if studied altogether. Therefore these respective isotope tracer measures will be run in only one-half of the participants from each Aim. 30 participants in the endurance training group and 30 participants in the resistance training group will complete Aims 1 and 2. A different 30 participants in the endurance training group and 30 in the resistance training group will complete Aim 3. Among the 60 participants (30 from each exercise training group) completing Aims 1 and 2, there will be 15 individuals from each exercise training group who will be randomized to undergo the tracer measures during exercise while the other 15 from each exercise training group addressing Aims 1 and 2 will complete the exercise protocol without the tracer methods. These randomization methods will also be applied to the 60 participants completing Aim 3, although these participants will undergo a hyperinsulinemic-euglycemic clamp with or without the tracer methods.
Participants will be recruited, screened, enrolled, and tested during months 4-55 of this grant. Participant recruitment procedures and procurement of needed supplies will occur during the first 3 months of the project. Additional recruitment, as well as screening and testing of participants will occur at 1-2 per month over the ensuing 52 months. Two microdialysis experiments will be performed on participants, one before and one after 12 weeks of exercise training, for a total of 240 microdialysis experiments. This plan will therefore require 4-5 microdialysis tests per month on average during the testing months. Stable label palmitate and glycerol isotope experiments will be conducted in 30 of the 60 participants undergoing the acute walking microdialysis experiments and in 30 of the 60 participants undergoing the clamp experiment. Deuterium water isotope experiments (studies of lipogenesis and adipogenesis) will be conducted in 60 of the participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise | Experimental | Behavioral: Resistance ExerciseParticipants do regular resistance exercise for 12 weeks. |
| Endurance Exercise | Experimental | Behavioral: Endurance ExerciseParticipants do regular endurance exercise for 12 weeks. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women
- Postmenopausal (50-75 yrs.)
- Obese (BMI 30-50 kg/m2)
- Prediabetes (HbA1c 5.7 - 6.4% or fasting blood glucose 100 to 125 mg/dL, or 2hr OGTT blood glucose 140 to 199 mg/dL)
- Sedentary (not performing purposeful exercise training more than 20 minutes per day twice a week)
Key exclusion criteria (9 listed)
- Engaging in purposeful resistance training or endurance training (> 20min/day, > 2 days/week)
- Resting blood pressure above 140 mmHg systolic or 90 mmHg diastolic
- Type 1 or type 2 diabetes
- Medical problems in which exercise is contraindicated, such as chronic infections
- History of, or currently presentation with, cancer, cardiovascular or respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance ExerciseAlso: Weight Lifting200 Kcal worth of weightlifting, 3 times/week for 12 weeks | Behavioural | Resistance Exercise |
| Endurance ExerciseAlso: Aerobic Exercise200 Kcal worth of treadmill walking, 3 times/week for 12 weeks | Behavioural | Endurance Exercise |
Primary outcome
Change from baseline subcutaneous abdominal adipose tissue glycerol concentration at 12 weeks
Time frame: 12 weeks of resistance or endurance training
Changes in physical activity (walking)-stimulated lipolysis will be assessed as measured by glycerol concentration in dialysate samples from subcutaneous abdominal adipose tissue utilizing a powerful in-vivo microdialysis methodology
Change from baseline gluteal adipose tissue glycerol concentration at 12 weeks
Time frame: 12 weeks of resistance or endurance training
Changes in physical activity (walking)-stimulated lipolysis will be assessed as measured by glycerol concentration in dialysate samples from gluteal adipose tissue utilizing a powerful in-vivo microdialysis methodology
Change from baseline whole-body lipolysis at 12 weeks
Time frame: 12 weeks of resistance or endurance training
Whole body lipolysis will be measured using whole body rate of appearance of 2H5-glycerol in blood samples collected at rest, during walking exercise, and for 120 minutes after exercise.
7 secondary outcomes
Change in blood flow as measured by ethanol concentrations in dialysate samples from subcutaneous abdominal adipose tissue
Time frame: 12 weeks of resistance or endurance training
Change in dialysate ethanol data in subcutaneous gluteal adipose tissue
Time frame: 12 weeks of resistance or endurance training
Change in the ratio of 13CO2 to 12CO2 in breath samples
Time frame: 12 weeks of resistance or endurance training
change in body composition
Time frame: 12 weeks of resistance or endurance training
Change in blood growth hormone concentrations
Time frame: 12 weeks of resistance or endurance training
Change in lipogenesis
Time frame: 12 weeks of resistance or endurance training
Change in adipogenesis
Time frame: 12 weeks of resistance or endurance training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 27936084Bonafiglia JT, Rotundo MP, Whittall JP, Scribbans TD, Graham RB, Gurd BJ. Inter-Individual Variability in the Adaptive Responses to Endurance and Sprint Interval Training: A Randomized Crossover Study. PLoS One. 2016 Dec 9;11(12):e0167790. doi: 10.1371/journal.pone.0167790. eCollection 2016.
- Background: PubMed 12145010Kim J, Wang Z, Heymsfield SB, Baumgartner RN, Gallagher D. Total-body skeletal muscle mass: estimation by a new dual-energy X-ray absorptiometry method. Am J Clin Nutr. 2002 Aug;76(2):378-83. doi: 10.1093/ajcn/76.2.378.
- Background: PubMed 10907753Hopkins WG. Measures of reliability in sports medicine and science. Sports Med. 2000 Jul;30(1):1-15. doi: 10.2165/00007256-200030010-00001.
- Background: PubMed 22231607Culver AL, Ockene IS, Balasubramanian R, Olendzki BC, Sepavich DM, Wactawski-Wende J, Manson JE, Qiao Y, Liu S, Merriam PA, Rahilly-Tierny C, Thomas F, Berger JS, Ockene JK, Curb JD, Ma Y. Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative. Arch Intern Med. 2012 Jan 23;172(2):144-52. doi: 10.1001/archinternmed.2011.625. Epub 2012 Jan 9.
- Background: PubMed 11052958Kim JY, Hickner RC, Cortright RL, Dohm GL, Houmard JA. Lipid oxidation is reduced in obese human skeletal muscle. Am J Physiol Endocrinol Metab. 2000 Nov;279(5):E1039-44. doi: 10.1152/ajpendo.2000.279.5.E1039.
- Background: PubMed 10566624Hickner RC, Racette SB, Binder EF, Fisher JS, Kohrt WM. Suppression of whole body and regional lipolysis by insulin: effects of obesity and exercise. J Clin Endocrinol Metab. 1999 Nov;84(11):3886-95. doi: 10.1210/jcem.84.11.6137.
- Background: PubMed 10770188Hickner RC, Racette SB, Binder EF, Fisher JS, Kohrt WM. Effects of 10 days of endurance exercise training on the suppression of whole body and regional lipolysis by insulin. J Clin Endocrinol Metab. 2000 Apr;85(4):1498-504. doi: 10.1210/jcem.85.4.6550.
- Background: PubMed 9612234Sial S, Coggan AR, Hickner RC, Klein S. Training-induced alterations in fat and carbohydrate metabolism during exercise in elderly subjects. Am J Physiol. 1998 May;274(5):E785-90. doi: 10.1152/ajpendo.1998.274.5.E785.
- Background: PubMed 1442130Hickner RC, Rosdahl H, Borg I, Ungerstedt U, Jorfeldt L, Henriksson J. The ethanol technique of monitoring local blood flow changes in rat skeletal muscle: implications for microdialysis. Acta Physiol Scand. 1992 Sep;146(1):87-97. doi: 10.1111/j.1748-1716.1992.tb09396.x.
- Background: PubMed 25921578Pierce JR, Maples JM, Hickner RC. IL-15 concentrations in skeletal muscle and subcutaneous adipose tissue in lean and obese humans: local effects of IL-15 on adipose tissue lipolysis. Am J Physiol Endocrinol Metab. 2015 Jun 15;308(12):E1131-9. doi: 10.1152/ajpendo.00575.2014. Epub 2015 Apr 28.
- Background: PubMed 23531620Gavin KM, Cooper EE, Raymer DK, Hickner RC. Estradiol effects on subcutaneous adipose tissue lipolysis in premenopausal women are adipose tissue depot specific and treatment dependent. Am J Physiol Endocrinol Metab. 2013 Jun 1;304(11):E1167-74. doi: 10.1152/ajpendo.00023.2013. Epub 2013 Mar 26.
- Background: PubMed 19265063Ormsbee MJ, Choi MD, Medlin JK, Geyer GH, Trantham LH, Dubis GS, Hickner RC. Regulation of fat metabolism during resistance exercise in sedentary lean and obese men. J Appl Physiol (1985). 2009 May;106(5):1529-37. doi: 10.1152/japplphysiol.91485.2008. Epub 2009 Mar 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert C Hickner, PhD principal investigator
Florida State University
Michael J Ormsbee, PhD principal investigator
Florida State University
Mostafa M Ali, PhD study director
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise and Endurance Exercise in people with Postmenopausal Symptoms and Obesity, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert C Hickner, PhD (850-644-1375, rhickner@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline subcutaneous abdominal adipose tissue glycerol concentration at 12 weeks (time frame: 12 weeks of resistance or endurance training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05351476, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.