DiabetesCREGNCT00777621
Caloric Restriction, Exercise, and Glucoregulation in Humans
A study testing Calorie Restriction, Exercise and Calorie Restriction and Exercise in people with Diabetes, run by St. Louis University at 1 site in United States.
Trial summary
Weight loss induced by caloric restriction alone (CR) and by exercise alone (EX) result in similar effects on blood glucose and insulin. The purpose of this study is to assess the hypothesis that weight loss through caloric restriction plus exercise will result in greater improvements on glucose tolerance and insulin… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Calorie Restriction, Exercise and Calorie Restriction and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- females postmenopausal
- no diabetes, cardiovascular disease, cancer
- no orthopedic problems
- not currently exercising
- BMI between 25 and 29.9
- nonsmokers
Who cannot join
- current regular exercisers
- premenopausal women
- cardiovascular disease, lung disease, cancer, diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Weight loss induced by caloric restriction alone (CR) and by exercise alone (EX) result in similar effects on blood glucose and insulin. The purpose of this study is to assess the hypothesis that weight loss through caloric restriction plus exercise will result in greater improvements on glucose tolerance and insulin action than similar weight losses through CR or EX alone.
Read the detailed description
Participants are randomized into caloric restriction, exercise, and caloric restriction plus exercise weight loss groups. Measurements of blood glucose and insulin, oral glucose tolerance, and matched glucose infusion will be done at baseline and after weight loss of 6% of body weight. Other tests include maximal oxygen uptake (VO2max), strength tests, blood pressure, blood lipids, serum inflammatory markers, dual X-ray absorptiometry (DEXA) for bone density and body composition, physical activity levels, dietary intakes, and measures of arterial stiffness.
- Conditions
- Diabetes
- Being tested
- Calorie Restriction, Exercise, Calorie Restriction and Exercise
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie RestrictionOther
This group will undergo a 20% reduction in energy intake without any change in energy expenditure.
ExerciseOther
This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.
Calorie Restriction and ExerciseOther
This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.
| Study group | Role | What they receive |
|---|---|---|
| Calorie restriction | Active comparator | Not described Receives: Other: Calorie Restriction |
| Exercise | Active comparator | Not described Receives: Other: Exercise |
| Calorie restriction and exercise | Experimental | Not described Receives: Other: Calorie Restriction and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucoregulatory function
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Weiss, Ph.D., St. Louis University
- Investigators
- Edward P Weiss, PhD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777621
- Sponsor's protocol ID
- K01DK080886
- Other IDs
- K01DK080886, 1K01DK080886-01
- Acronym
- CREG
- Status last verified
- Feb 2016
- First submitted
- 21 Oct 2008
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Weiss EP, Jordan RC, Frese EM, Albert SG, Villareal DT. Effects of Weight Loss on Lean Mass, Strength, Bone, and Aerobic Capacity. Med Sci Sports Exerc. 2017 Jan;49(1):206-217. doi: 10.1249/MSS.0000000000001074.
PubMed 27580151Weiss EP, Albert SG, Reeds DN, Kress KS, McDaniel JL, Klein S, Villareal DT. Effects of matched weight loss from calorie restriction, exercise, or both on cardiovascular disease risk factors: a randomized intervention trial. Am J Clin Nutr. 2016 Sep;104(3):576-86. doi: 10.3945/ajcn.116.131391. Epub 2016 Jul 27.
PubMed 27465384Weiss EP, Albert SG, Reeds DN, Kress KS, Ezekiel UR, McDaniel JL, Patterson BW, Klein S, Villareal DT. Calorie Restriction and Matched Weight Loss From Exercise: Independent and Additive Effects on Glucoregulation and the Incretin System in Overweight Women and Men. Diabetes Care. 2015 Jul;38(7):1253-62. doi: 10.2337/dc14-2913. Epub 2015 Apr 15.
PubMed 25877812
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caloric Restriction, Exercise, and Glucoregulation in Humans
- ClinicalTrials.gov ID
- NCT00777621
- Acronym / sponsor ID
- CREG / K01DK080886
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2008
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Oct 2008 (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.
Weight loss induced by caloric restriction alone (CR) and by exercise alone (EX) result in similar effects on blood glucose and insulin. The purpose of this study is to assess the hypothesis that weight loss through caloric restriction plus exercise will result in greater improvements on glucose tolerance and insulin action than similar weight losses through CR or EX alone.
Detailed description
Participants are randomized into caloric restriction, exercise, and caloric restriction plus exercise weight loss groups. Measurements of blood glucose and insulin, oral glucose tolerance, and matched glucose infusion will be done at baseline and after weight loss of 6% of body weight. Other tests include maximal oxygen uptake (VO2max), strength tests, blood pressure, blood lipids, serum inflammatory markers, dual X-ray absorptiometry (DEXA) for bone density and body composition, physical activity levels, dietary intakes, and measures of arterial stiffness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calorie restriction | Active comparator | Other: Calorie Restriction |
| Exercise | Active comparator | Other: Exercise |
| Calorie restriction and exercise | Experimental | Other: Calorie Restriction and Exercise |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- females postmenopausal
- no diabetes, cardiovascular disease, cancer
- no orthopedic problems
- not currently exercising
- BMI between 25 and 29.9
Key exclusion criteria (3 listed)
- current regular exercisers
- premenopausal women
- cardiovascular disease, lung disease, cancer, diabetes
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 |
|---|---|---|
| Calorie RestrictionThis group will undergo a 20% reduction in energy intake without any change in energy expenditure. | Other | Calorie restriction |
| ExerciseThis group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake. | Other | Exercise |
| Calorie Restriction and ExerciseThis group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise. | Other | Calorie restriction and exercise |
Primary outcome
Glucoregulatory function
Time frame: 3-4 months
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 12 Feb 2016.
- Derived from this study: PubMed 27580151Weiss EP, Jordan RC, Frese EM, Albert SG, Villareal DT. Effects of Weight Loss on Lean Mass, Strength, Bone, and Aerobic Capacity. Med Sci Sports Exerc. 2017 Jan;49(1):206-217. doi: 10.1249/MSS.0000000000001074.
- Derived from this study: PubMed 27465384Weiss EP, Albert SG, Reeds DN, Kress KS, McDaniel JL, Klein S, Villareal DT. Effects of matched weight loss from calorie restriction, exercise, or both on cardiovascular disease risk factors: a randomized intervention trial. Am J Clin Nutr. 2016 Sep;104(3):576-86. doi: 10.3945/ajcn.116.131391. Epub 2016 Jul 27.
- Derived from this study: PubMed 25877812Weiss EP, Albert SG, Reeds DN, Kress KS, Ezekiel UR, McDaniel JL, Patterson BW, Klein S, Villareal DT. Calorie Restriction and Matched Weight Loss From Exercise: Independent and Additive Effects on Glucoregulation and the Incretin System in Overweight Women and Men. Diabetes Care. 2015 Jul;38(7):1253-62. doi: 10.2337/dc14-2913. Epub 2015 Apr 15.
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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.
Edward P Weiss, PhD principal investigator
St. Louis 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 Calorie Restriction, Exercise and Calorie Restriction and Exercise in people with Diabetes, run by St. Louis 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 6 inclusion and 3 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 12 Feb 2016. 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?
Glucoregulatory function (time frame: 3-4 months). 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 NCT00777621, which also lists 3 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 12 Feb 2016.