HealthyNCT03133156
Exercise Regulation of Human Adipose Tissue
A study testing Exercise Intervention in people with Healthy and Obese, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether exercise training leads to changes in the white adipose tissue that are beneficial to the body's regulation of sugar and body weight. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Obese, Diabetes Mellitus, Type 2
- What is being tested?
- Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 25-55 years old at the time of screening
- Body mass index (BMI) must be:
- ≥20 and ≤ 27 kg/m2 for lean subjects
- ≥25 and ≤ 37 kg/m2 for subjects with type 2 diabetes
- ≥27 and ≤ 37 kg/m2 for obese/overweight subjects
- HbA1c values:
- ≤5.7 ± 0.1% for lean and overweight/obese subjects
- 6.5 ± 0.1% - 9.0 ± 0.1% for subjects with type 2 diabetes
Who cannot join
- Age <25 and >55 years old
- Type 1 Diabetes
- HbA1c ≥ 9.0%
- Heart or lung disease
- Basal-Bolus Insulin regimen
- Use of beta-blockers or thiazolidinediones
Show all 19Show fewer
- Acute systemic infection accompanied by fever, body aches, or swollen lymph glands
- BMI ≥ 37 kg/m2
- Current dieting or weight loss efforts
- Current pregnant or breastfeeding
- Known history of HIV/AIDS or certain cancers
- Biochemical evidence of renal or hepatic dysfunction; renal or liver disease
- Demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis
- Recent blood donation
- Clinical history of stroke
- Severe hypertension (systolic > 160 mmHg or diastolic > 90 mmHg)
- Inability to exercise at 50% of predicted heart rate (HR) reserve at baseline
- Participants who screen positive for The American Heart Association's contraindications to exercise testing
- History of keloid formation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether exercise training leads to changes in the white adipose tissue that are beneficial to the body's regulation of sugar and body weight.
Read the detailed description
The prevalence of obesity and type 2 diabetes in the United States and worldwide has risen dramatically over the last few decades, resulting in an enormous need for new therapies to treat these conditions. The discovery that beiging of subcutaneous white adipose tissue may increase energy expenditure has led to tremendous interest in beige cells as a potential treatment for diabetes and obesity. An established treatment for type 2 diabetes and obesity is endurance exercise training. Exercise training can improve systemic homeostasis, and although adaptations to skeletal muscle play a critical role in these effects, the underlying mechanisms are not fully understood. Moreover, the contributions of other tissues in these beneficial effects of exercise on metabolism have not been intensively investigated. The study team hypothesizes that exercise training results in fundamental changes to white adipose tissue, including beiging, and these adaptations play an important role in the effects of exercise training to improve metabolic homeostasis.
- Conditions
- Healthy, Obese, Diabetes Mellitus, Type 2
- Being tested
- Exercise Intervention
- Keywords
- Exercise, Training, Type 2 Diabetes, Mellitus
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionOther
10-Week Aerobic Exercise Training
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Training-Healthy Lean | Experimental | Eligible subjects will undergo a 10-week moderate intensity exercise program. Receives: Other: Exercise Intervention |
| Moderate Intensity Training-Healthy Overweight/Obese | Experimental | Eligible subjects will undergo a 10-week moderate intensity exercise program. Receives: Other: Exercise Intervention |
| Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Experimental | Eligible subjects will undergo a 10-week moderate intensity exercise program. Receives: Other: Exercise Intervention |
| High Intensity Training-Healthy Lean. | Experimental | Eligible subjects will undergo a 10-week high intensity exercise program Receives: Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Human Adipose Tissue Characteristics Following Exercise Training
Body fat percentage measured before and after exercise training with a bioelectrical impedance scale.
Measured: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.
Changes in Human Adipose Tissue Characteristics Following Exercise Training
Body fat mass measured before and after exercise training with a bioelectrical impedance scale.
Measured: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.
Changes in Human Adipose Tissue Characteristics Following Exercise Training
Body weight measured before and after exercise training with a bioelectrical impedance scale.
Measured: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise 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 2017
- Study start15 Jun 2017
- Primary completion17 Jan 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The current research will consist of 2 different exercise training protocols. Subjects will be randomized into each Arm based on screening criteria and compared to the control (Arm 1)
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie J Goodyear, PhD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133156
- Sponsor's protocol ID
- 2016-33
- Other IDs
- R01DK112283
- Status last verified
- Aug 2025
- First submitted
- 22 Feb 2017
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Regulation of Human Adipose Tissue
- ClinicalTrials.gov ID
- NCT03133156
- Acronym / sponsor ID
- 2016-33
- Conditions
- Healthy, Obese, Diabetes Mellitus, Type 2
- Keywords
- Exercise, Training, Type 2 Diabetes, Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Posted 14 Aug 2025
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 determine whether exercise training leads to changes in the white adipose tissue that are beneficial to the body's regulation of sugar and body weight.
Detailed description
The prevalence of obesity and type 2 diabetes in the United States and worldwide has risen dramatically over the last few decades, resulting in an enormous need for new therapies to treat these conditions. The discovery that beiging of subcutaneous white adipose tissue may increase energy expenditure has led to tremendous interest in beige cells as a potential treatment for diabetes and obesity. An established treatment for type 2 diabetes and obesity is endurance exercise training. Exercise training can improve systemic homeostasis, and although adaptations to skeletal muscle play a critical role in these effects, the underlying mechanisms are not fully understood. Moreover, the contributions of other tissues in these beneficial effects of exercise on metabolism have not been intensively investigated. The study team hypothesizes that exercise training results in fundamental changes to white adipose tissue, including beiging, and these adaptations play an important role in the effects of exercise training to improve metabolic homeostasis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The current research will consist of 2 different exercise training protocols. Subjects will be randomized into each Arm based on screening criteria and compared to the control (Arm 1)
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Training-Healthy Lean | Experimental | Other: Exercise InterventionEligible subjects will undergo a 10-week moderate intensity exercise program. |
| Moderate Intensity Training-Healthy Overweight/Obese | Experimental | Other: Exercise InterventionEligible subjects will undergo a 10-week moderate intensity exercise program. |
| Moderate Intensity Training-Overweight/Obese Type 2 Diabetes | Experimental | Other: Exercise InterventionEligible subjects will undergo a 10-week moderate intensity exercise program. |
| High Intensity Training-Healthy Lean. | Experimental | Other: Exercise InterventionEligible subjects will undergo a 10-week high intensity exercise program |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 25-55 years old at the time of screening
- Body mass index (BMI) must be:
- HbA1c values:
Key exclusion criteria (19 listed)
- Age <25 and >55 years old
- Type 1 Diabetes
- HbA1c ≥ 9.0%
- Heart or lung disease
- Basal-Bolus Insulin regimen
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 |
|---|---|---|
| Exercise Intervention10-Week Aerobic Exercise Training | Other | High Intensity Training-Healthy Lean., Moderate Intensity Training-Healthy Lean, Moderate Intensity Training-Healthy Overweight/Obese, Moderate Intensity Training-Overweight/Obese Type 2 Diabetes |
Primary outcome
Changes in Human Adipose Tissue Characteristics Following Exercise Training
Time frame: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.
Body fat percentage measured before and after exercise training with a bioelectrical impedance scale.
Changes in Human Adipose Tissue Characteristics Following Exercise Training
Time frame: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.
Body fat mass measured before and after exercise training with a bioelectrical impedance scale.
Changes in Human Adipose Tissue Characteristics Following Exercise Training
Time frame: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise training.
Body weight measured before and after exercise training with a bioelectrical impedance scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Laurie J Goodyear, PhD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Healthy and Obese, run by Joslin Diabetes Center 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 8 inclusion and 19 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 14 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Human Adipose Tissue Characteristics Following Exercise Training (time frame: Baseline measurement (week 0, prior to starting exercise training) and post-intervention measurement at week 10, after completion of exercise 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?
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 14 Aug 2025.