Exercise Training and Fat Metabolism in Postmenopausal Women

NCT05351476 | Recruiting DMC

• 2 other identifiers: STUDY00001939R01DK125728
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Postmenopausal Symptoms; Obesity; Prediabetic State

Keywords

Resistance Exercise; Fat Metabolism; Postmenopause

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  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

  12 weeks of resistance or endurance training

• Change in dialysate ethanol data in subcutaneous gluteal adipose tissue

  12 weeks of resistance or endurance training

• Change in the ratio of 13CO2 to 12CO2 in breath samples

  12 weeks of resistance or endurance training

• change in body composition

  12 weeks of resistance or endurance training

• Change in blood growth hormone concentrations

  12 weeks of resistance or endurance training

Study Arms (2)

Resistance Exercise

EXPERIMENTAL

Participants do regular resistance exercise for 12 weeks.

Behavioral: Resistance Exercise

Endurance Exercise

EXPERIMENTAL

Participants do regular endurance exercise for 12 weeks.

Behavioral: Endurance Exercise

Interventions

Resistance Exercise BEHAVIORAL

200 Kcal worth of weightlifting, 3 times/week for 12 weeks

Also known as: Weight Lifting

Resistance Exercise

Endurance Exercise BEHAVIORAL

200 Kcal worth of treadmill walking, 3 times/week for 12 weeks

Also known as: Aerobic Exercise

Endurance Exercise

Eligibility Criteria

• Age: 50 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Florida State University: lead
• Pennington Biomedical Research Center: collaborator
• University of Arkansas: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 27936084 BACKGROUND

• Kim 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.

  PMID: 12145010 BACKGROUND

• Hopkins WG. Measures of reliability in sports medicine and science. Sports Med. 2000 Jul;30(1):1-15. doi: 10.2165/00007256-200030010-00001.

  PMID: 10907753 BACKGROUND

• Culver 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.

  PMID: 22231607 BACKGROUND

• Kim 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.

  PMID: 11052958 BACKGROUND

• Hickner 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.

  PMID: 10566624 BACKGROUND

• Hickner 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.

  PMID: 10770188 BACKGROUND

• Sial 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.

  PMID: 9612234 BACKGROUND

• Hickner 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.

  PMID: 1442130 BACKGROUND

• Pierce 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.

  PMID: 25921578 BACKGROUND

• Gavin 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.

  PMID: 23531620 BACKGROUND

• Ormsbee 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.

  PMID: 19265063 BACKGROUND

• Ormsbee 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.

  PMID: 17507738 BACKGROUND

MeSH Terms

Conditions

Obesity; Prediabetic State

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

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

Study Officials

• Robert C Hickner, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

• Michael J Ormsbee, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

• Mostafa M Ali, PhD

  Florida State University

  STUDY DIRECTOR

Central Study Contacts

Robert C Hickner, PhD

CONTACT

850-644-1375; rhickner@fsu.edu

Michael J Ormsbee, PhD

CONTACT

850-644-2194; mormsbee@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 28, 2022
• Study Start: May 20, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)