ObesityNCT00882141
Race, Menopause and Metabolism After Exercise and Diet
A study testing Diet modification and Aerobic exercise in people with Obesity and Insulin Resistance, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to test the hypotheses that there are ethnic and genetic differences in the mechanisms and magnitude by which hypocaloric weight loss and aerobic exercise affect body composition, glucose, lipid, muscle and adipose tissue metabolism in overweight, insulin resistant postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Sedentary Lifestyle
- What is being tested?
- Diet modification and Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- 45-80 yrs of age
- Non-smoking for one year
- BMI greater than 25 kg/m2 and less than 50 kg/m2
- Menopause over 1 year
- Caucasian or African American ethnicity
Who cannot join
- Both groups
- Currently being treated for active cancer
- Type 1 diabetes; insulin treatment; poorly controlled (fasting blood sugar over 160 mg/dl)
- Allergic to lidocaine or heparin
- Untreated dyslipidemia, receiving triglyceride-lowering meds
- Other systemic disorders that are not medically treated and stable
Show all 16Show fewer
- Taking beta-blockers, oral steroids, warfarin or any other medications interfering with fat/muscle metabolism that may not be safely discontinued temporarily for specific procedures (i.e. for 72 hours prior)
- Abnormal liver or renal function; chronic pulmonary disease (on supplemental oxygen); anemia
- MMSE (Mini-Mental State Examination) below 24, dementia or unstable clinical depression by exam
- Women of ethnicity other than Caucasian or African American
- Symptomatic heart disease, coronary artery disease, congestive heart failure, or uncontrolled hypertension unless medically stabilized
- Abnormal response to exercise test (chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising blood pressure above 240/120mm Hg, or other contraindications to exercise)
- Exercise plus weight loss group only
- Medical history of CVD (cardiovascular disease) with symptoms limiting ability to exercise
- Physical impairment limiting normal activity
- Aerobically trained with VO2max greater than 2 SD (standard deviation) above age-adjusted mean
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, VAMC
Baltimore, Maryland, 20705
About this study
Official title: Menopause, Genes and Metabolism After Weight Loss and Exercise
The purpose of this study is to test the hypotheses that there are ethnic and genetic differences in the mechanisms and magnitude by which hypocaloric weight loss and aerobic exercise affect body composition, glucose, lipid, muscle and adipose tissue metabolism in overweight, insulin resistant postmenopausal women. This will be tested in a trial comparing the effects of weight loss vs. aerobic exercise plus weight loss on glucose, lipid, fat and muscle metabolism in overweight African American and Caucasian postmenopausal women.
Read the detailed description
The findings of this study will also determine whether there are racial differences in the whole body and cellular mechanisms by which aerobic exercise training and weight loss affect glucose, lipid, fat and muscle metabolism in African-American vs. Caucasian postmenopausal women. The results also may provide a rationale for targeting specific populations of women who might improve glucose, lipid, fat and muscle metabolism more from the addition of exercise to dietary restriction than weight loss alone to reduce their risk for type 2 diabetes and cardiovascular disease.
The study protocol consists of the following phases:
Phase 1-Recruitment and screening.
Phase 2-Weight and dietary stabilization for 4-6 weeks, where participants are taught the principles of the American Heart Association "Heart Healthy" diet and provided food to consume prior to testing.
Phase 3-Participants will undergo research testing including glucose clamp and fat biopsy.
Phase 4-Participants select either weight loss only, or exercise plus weight loss. The behavior diet modification weight loss sessions are held by a registered dietitian for 1 hour once a week for 6-9 months where the recommended caloric intake for each participant is adjusted by the dietitian to elicit a weight loss of approximately 0.2-0.4 kg per week. In addition to the weight loss sessions, participants who select the aerobic exercise plus weight loss intervention will exercise at the Baltimore Geriatric Research Education and Clinical Center (GRECC) exercise facility 3 times a week for 6-9 months using treadmills and other aerobic exercise equipment. Exercise sessions begin at low levels of VO2max (maximal oxygen consumption) and progress in duration and intensity until the participant is able to exercise at more than 75% VO2max for 45 minutes.
Phase 5-Following the 6-9 months of long-term weight loss or exercise plus weight loss, all participants will undergo long-term metabolic testing.
- Conditions
- Obesity, Insulin Resistance, Sedentary Lifestyle
- Being tested
- Diet modification, Aerobic exercise
- Keywords
- Exercise, Obesity, Insulin Sensitivity
- Medical subject headings
- Obesity, Insulin Resistance, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet modificationBehavioural
Also called American Heart Association "Heart Healthy" diet
Weight loss sessions are held by a registered dietitian for 1 hour once a week for 6-9 months; recommended caloric intake to elicit a weight loss of approximately 0.2-0.4 kg per week
Aerobic exerciseBehavioural
Treadmills and other aerobic exercise equipment 3 times a week for 6-9 months, beginning at low levels of VO2max and progressing in duration and intensity to more than 75% VO2max for 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Weight loss Receives: Behavioral: Diet modification |
| 2 | Experimental | Exercise plus weight loss Receives: Behavioral: Diet modification; Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Clamp
Measured: At 4-6 weeks
Fat biopsy
Measured: At 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startMar 2002
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Alice S. Ryan, PhD, Principal investigator, University of Maryland, VA Research ServiceAndrew P. Goldberg, MD, Principal investigator, University of Maryland, VA Research Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882141
- Sponsor's protocol ID
- AG0116
- Other IDs
- R01AG019310, R01AG020116
- Status last verified
- Jan 2010
- First submitted
- 15 Apr 2009
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berman DM, Rodrigues LM, Nicklas BJ, Ryan AS, Dennis KE, Goldberg AP. Racial disparities in metabolism, central obesity, and sex hormone-binding globulin in postmenopausal women. J Clin Endocrinol Metab. 2001 Jan;86(1):97-103. doi: 10.1210/jcem.86.1.7147.
PubMed 11231984Ryan AS, Nicklas BJ, Berman DM. Racial differences in insulin resistance and mid-thigh fat deposition in postmenopausal women. Obes Res. 2002 May;10(5):336-44. doi: 10.1038/oby.2002.47.
PubMed 12006632Nicklas BJ, Dennis KE, Berman DM, Sorkin J, Ryan AS, Goldberg AP. Lifestyle intervention of hypocaloric dieting and walking reduces abdominal obesity and improves coronary heart disease risk factors in obese, postmenopausal, African-American and Caucasian women. J Gerontol A Biol Sci Med Sci. 2003 Feb;58(2):181-9. doi: 10.1093/gerona/58.2.m181.
PubMed 12586858Ryan AS, Nicklas BJ, Berman DM. Aerobic exercise is necessary to improve glucose utilization with moderate weight loss in women. Obesity (Silver Spring). 2006 Jun;14(6):1064-72. doi: 10.1038/oby.2006.122.
PubMed 16861612Ryan AS, Serra MC, Goldberg AP. Metabolic Benefits of Prior Weight Loss with and without Exercise on Subsequent 6-Month Weight Regain. Obesity (Silver Spring). 2018 Jan;26(1):37-44. doi: 10.1002/oby.22032. Epub 2017 Oct 25.
PubMed 29071802Ortmeyer HK, Goldberg AP, Ryan AS. Exercise with weight loss improves adipose tissue and skeletal muscle markers of fatty acid metabolism in postmenopausal women. Obesity (Silver Spring). 2017 Jul;25(7):1246-1253. doi: 10.1002/oby.21877. Epub 2017 May 26.
PubMed 28547918Ge S, Ryan AS. Zinc-alpha2-glycoprotein expression in adipose tissue of obese postmenopausal women before and after weight loss and exercise + weight loss. Metabolism. 2014 Aug;63(8):995-9. doi: 10.1016/j.metabol.2014.04.013. Epub 2014 May 4.
PubMed 24929893Ryan AS, Ge S, Blumenthal JB, Serra MC, Prior SJ, Goldberg AP. Aerobic exercise and weight loss reduce vascular markers of inflammation and improve insulin sensitivity in obese women. J Am Geriatr Soc. 2014 Apr;62(4):607-14. doi: 10.1111/jgs.12749. Epub 2014 Mar 17.
PubMed 24635342Prior SJ, Blumenthal JB, Katzel LI, Goldberg AP, Ryan AS. Increased skeletal muscle capillarization after aerobic exercise training and weight loss improves insulin sensitivity in adults with IGT. Diabetes Care. 2014 May;37(5):1469-75. doi: 10.2337/dc13-2358. Epub 2014 Mar 4.
PubMed 24595633Yang RZ, Blumenthal JB, Glynn NM, Lee MJ, Goldberg AP, Gong DW, Ryan AS. Decrease of circulating SAA is correlated with reduction of abdominal SAA secretion during weight loss. Obesity (Silver Spring). 2014 Apr;22(4):1085-90. doi: 10.1002/oby.20657. Epub 2013 Dec 6.
PubMed 24311467Ryan AS, Li G, Blumenthal JB, Ortmeyer HK. Aerobic exercise + weight loss decreases skeletal muscle myostatin expression and improves insulin sensitivity in older adults. Obesity (Silver Spring). 2013 Jul;21(7):1350-6. doi: 10.1002/oby.20216. Epub 2013 May 19.
PubMed 23687104
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopause, Genes and Metabolism After Weight Loss and Exercise
- ClinicalTrials.gov ID
- NCT00882141
- Acronym / sponsor ID
- AG0116
- Conditions
- Obesity, Insulin Resistance, Sedentary Lifestyle
- Keywords
- Exercise, Obesity, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Mar 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Apr 2009 (estimated)
- 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.
The purpose of this study is to test the hypotheses that there are ethnic and genetic differences in the mechanisms and magnitude by which hypocaloric weight loss and aerobic exercise affect body composition, glucose, lipid, muscle and adipose tissue metabolism in overweight, insulin resistant postmenopausal women. This will be tested in a trial comparing the effects of weight loss vs. aerobic exercise plus weight loss on glucose, lipid, fat and muscle metabolism in overweight African American and Caucasian postmenopausal women.
Detailed description
The findings of this study will also determine whether there are racial differences in the whole body and cellular mechanisms by which aerobic exercise training and weight loss affect glucose, lipid, fat and muscle metabolism in African-American vs. Caucasian postmenopausal women. The results also may provide a rationale for targeting specific populations of women who might improve glucose, lipid, fat and muscle metabolism more from the addition of exercise to dietary restriction than weight loss alone to reduce their risk for type 2 diabetes and cardiovascular disease.
The study protocol consists of the following phases:
Phase 1-Recruitment and screening.
Phase 2-Weight and dietary stabilization for 4-6 weeks, where participants are taught the principles of the American Heart Association "Heart Healthy" diet and provided food to consume prior to testing.
Phase 3-Participants will undergo research testing including glucose clamp and fat biopsy.
Phase 4-Participants select either weight loss only, or exercise plus weight loss. The behavior diet modification weight loss sessions are held by a registered dietitian for 1 hour once a week for 6-9 months where the recommended caloric intake for each participant is adjusted by the dietitian to elicit a weight loss of approximately 0.2-0.4 kg per week. In addition to the weight loss sessions, participants who select the aerobic exercise plus weight loss intervention will exercise at the Baltimore Geriatric Research Education and Clinical Center (GRECC) exercise facility 3 times a week for 6-9 months using treadmills and other aerobic exercise equipment. Exercise sessions begin at low levels of VO2max (maximal oxygen consumption) and progress in duration and intensity until the participant is able to exercise at more than 75% VO2max for 45 minutes.
Phase 5-Following the 6-9 months of long-term weight loss or exercise plus weight loss, all participants will undergo long-term metabolic testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Diet modificationWeight loss |
| 2 | Experimental | Behavioral: Diet modification, Behavioral: Aerobic exerciseExercise plus weight loss |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- 45-80 yrs of age
- Non-smoking for one year
- BMI greater than 25 kg/m2 and less than 50 kg/m2
- Menopause over 1 year
Key exclusion criteria (16 listed)
- Both groups
- Currently being treated for active cancer
- Type 1 diabetes; insulin treatment; poorly controlled (fasting blood sugar over 160 mg/dl)
- Allergic to lidocaine or heparin
- Untreated dyslipidemia, receiving triglyceride-lowering meds
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 |
|---|---|---|
| Diet modificationAlso: American Heart Association "Heart Healthy" dietWeight loss sessions are held by a registered dietitian for 1 hour once a week for 6-9 months; recommended caloric intake to elicit a weight loss of approximately 0.2-0.4 kg per week | Behavioural | 1, 2 |
| Aerobic exerciseTreadmills and other aerobic exercise equipment 3 times a week for 6-9 months, beginning at low levels of VO2max and progressing in duration and intensity to more than 75% VO2max for 45 minutes | Behavioural | 2 |
Primary outcome
Glucose Clamp
Time frame: At 4-6 weeks
Fat biopsy
Time frame: At 4-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Background: PubMed 11231984Berman DM, Rodrigues LM, Nicklas BJ, Ryan AS, Dennis KE, Goldberg AP. Racial disparities in metabolism, central obesity, and sex hormone-binding globulin in postmenopausal women. J Clin Endocrinol Metab. 2001 Jan;86(1):97-103. doi: 10.1210/jcem.86.1.7147.
- Background: PubMed 12006632Ryan AS, Nicklas BJ, Berman DM. Racial differences in insulin resistance and mid-thigh fat deposition in postmenopausal women. Obes Res. 2002 May;10(5):336-44. doi: 10.1038/oby.2002.47.
- Background: PubMed 12586858Nicklas BJ, Dennis KE, Berman DM, Sorkin J, Ryan AS, Goldberg AP. Lifestyle intervention of hypocaloric dieting and walking reduces abdominal obesity and improves coronary heart disease risk factors in obese, postmenopausal, African-American and Caucasian women. J Gerontol A Biol Sci Med Sci. 2003 Feb;58(2):181-9. doi: 10.1093/gerona/58.2.m181.
- Background: PubMed 16861612Ryan AS, Nicklas BJ, Berman DM. Aerobic exercise is necessary to improve glucose utilization with moderate weight loss in women. Obesity (Silver Spring). 2006 Jun;14(6):1064-72. doi: 10.1038/oby.2006.122.
- Derived from this study: PubMed 29071802Ryan AS, Serra MC, Goldberg AP. Metabolic Benefits of Prior Weight Loss with and without Exercise on Subsequent 6-Month Weight Regain. Obesity (Silver Spring). 2018 Jan;26(1):37-44. doi: 10.1002/oby.22032. Epub 2017 Oct 25.
- Derived from this study: PubMed 28547918Ortmeyer HK, Goldberg AP, Ryan AS. Exercise with weight loss improves adipose tissue and skeletal muscle markers of fatty acid metabolism in postmenopausal women. Obesity (Silver Spring). 2017 Jul;25(7):1246-1253. doi: 10.1002/oby.21877. Epub 2017 May 26.
- Derived from this study: PubMed 24929893Ge S, Ryan AS. Zinc-alpha2-glycoprotein expression in adipose tissue of obese postmenopausal women before and after weight loss and exercise + weight loss. Metabolism. 2014 Aug;63(8):995-9. doi: 10.1016/j.metabol.2014.04.013. Epub 2014 May 4.
- Derived from this study: PubMed 24635342Ryan AS, Ge S, Blumenthal JB, Serra MC, Prior SJ, Goldberg AP. Aerobic exercise and weight loss reduce vascular markers of inflammation and improve insulin sensitivity in obese women. J Am Geriatr Soc. 2014 Apr;62(4):607-14. doi: 10.1111/jgs.12749. Epub 2014 Mar 17.
- Derived from this study: PubMed 24595633Prior SJ, Blumenthal JB, Katzel LI, Goldberg AP, Ryan AS. Increased skeletal muscle capillarization after aerobic exercise training and weight loss improves insulin sensitivity in adults with IGT. Diabetes Care. 2014 May;37(5):1469-75. doi: 10.2337/dc13-2358. Epub 2014 Mar 4.
- Derived from this study: PubMed 24311467Yang RZ, Blumenthal JB, Glynn NM, Lee MJ, Goldberg AP, Gong DW, Ryan AS. Decrease of circulating SAA is correlated with reduction of abdominal SAA secretion during weight loss. Obesity (Silver Spring). 2014 Apr;22(4):1085-90. doi: 10.1002/oby.20657. Epub 2013 Dec 6.
- Derived from this study: PubMed 23687104Ryan AS, Li G, Blumenthal JB, Ortmeyer HK. Aerobic exercise + weight loss decreases skeletal muscle myostatin expression and improves insulin sensitivity in older adults. Obesity (Silver Spring). 2013 Jul;21(7):1350-6. doi: 10.1002/oby.20216. Epub 2013 May 19.
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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. This study is not recruiting at the moment.
Alice S. Ryan, PhD principal investigator
University of Maryland, VA Research Service
Andrew P. Goldberg, MD principal investigator
University of Maryland, VA Research Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet modification and Aerobic exercise in people with Obesity and Insulin Resistance, run by National Institute on Aging (NIA) 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 6 inclusion and 16 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: finished, as of the sponsor's last update on 13 Jan 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Clamp (time frame: At 4-6 weeks). The study lists 2 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 NCT00882141, which also lists 11 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 Jan 2010.