Type 2 DiabetesEXPETNCT04754581
Dynamic in Vivo PET Imaging and ex Vivo Biopsies From Skeletal Muscle and Adipose Tissue to Investigate the Effects of Exercise on Insulin Resistance and Mitochondrial Energetics in Type 2 Diabetes
A study testing Maximal ATP Production (ATPmax), Exercise Testing (VO2max) and Muscle Biopsy in people with Type 2 Diabetes, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The overall aim of this pilot study is to investigate the effects of exercise training on skeletal muscle and adipose tissue insulin resistance in subjects with Type 2 Diabetes (T2D). Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Maximal ATP Production (ATPmax), Exercise Testing (VO2max) and Muscle Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to Dec 2026
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30-65 years
- Men and women
- Body mass index (BMI) between 25 and 45 kg/m2
- Sedentary (1 day or less per week of structured exercise)
- Type 2 diabetes mellitus determined by self-report or by a fasting glucose >126mg/dl
- Weight stable (± 2 kg) for prior 3 months
- Willing to commit to the schedule of assessment visits, including the exercise intervention
Who cannot join
- Currently taking insulin, injectable incretin mimetics and thiazolidinediones
- Taking more than two glucose-lowering medications
- Resting blood pressure ≥ 160/100 mm Hg
- Triglycerides ≥ 500 mg/dL
- Any renal, cardiac, liver, lung, or neurological disease that in the opinion of the principal investigator would compromise participant safety or the participants' ability to complete the exercise training protocol
- Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)
Show all 28Show fewer
- Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise training
- Pulse check ("Allen test") indicates participant has poor blood flow in the hands
- Cancer (active malignancy with or without concurrent chemotherapy; except for basal cell carcinoma)
- Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next year
- Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
- Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures
- Participant is currently taking anti-inflammatory medication or has had inflammatory medication within 1 week prior to screening (including over the counter formulations: e.g. Aleve, Motrin, Ibuprofen, Naproxen, low dose ASA.
- New onset (<3 months on a stable regime) hormone replacement therapy
- Current use of beta-adrenergic blocking agents
- Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
- Increased liver function tests (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal)
- Abnormal blood count/anemia, blood transfusion or blood donation within the last 2 months
- Current smokers (smoking within the past 3 months prior to screening visit, including any/all tobacco products)
- Current drug or alcohol abuse/dependence
- Metal implants (pace-maker, aneurysm clips) based on investigator's judgment at screening
- Not physically capable of performing the exercise required of the study protocols
- Plans to be away >2 weeks in the next 3 months
- Unable to participate in Magnetic Resonance Imaging (MRI) assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on investigator's judgment at screening.
- Unable to tolerate MRI or claustrophobia.
- Nickel allergy
- Lidocaine allergy
- Unable or unwilling to communicate with staff or to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
AdventHealth Translational Research Institute
Orlando, Florida, 32804
About this study
The overall aim of this pilot study is to investigate the effects of exercise training on skeletal muscle and adipose tissue insulin resistance in subjects with Type 2 Diabetes (T2D).
- Conditions
- Type 2 Diabetes
- Being tested
- Maximal ATP Production (ATPmax), Exercise Testing (VO2max), Muscle Biopsy, Adipose Tissue Biopsy, Hyperinsulinemic euglycemic clamp
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal ATP Production (ATPmax)Other
ATPmax will be measured in order to determine in vivo mitochondrial capacity. The magnetic resonance scans to measure mitochondrial energetics will also be performed.
Exercise Testing (VO2max)Other
Aerobic fitness level will be assessed while participant pedals on a stationary bicycle/walk on a treadmill. The volume of oxygen intake and carbon dioxide (CO2) production will be measured.
Muscle BiopsyProcedure or surgery
Sample muscle cells from the left leg Vastus Lateralis (thigh) muscle.
Adipose Tissue BiopsyProcedure or surgery
Sample fat tissue from the abdomen.
Hyperinsulinemic euglycemic clampOther
Measurement of insulin sensitivity.
PET imagingOther
After an overnight fast, an intravenous catheter will be placed in each arm (one with arterial line for PET infusion, and the other for infusion of insulin, glucose, and 6,6 D2 glucose tracer. FDG-glucose will be injected followed by 90-minute PET scanning of the thigh.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Other | Not described Receives: Other: Maximal ATP Production (ATPmax); Other: Exercise Testing (VO2max); Procedure: Muscle Biopsy; Procedure: Adipose Tissue Biopsy; Other: Hyperinsulinemic euglycemic clamp; Other: PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual steps of muscle glucose uptake (pre-exercise)
Muscle glucose uptake will be assessed two times (pre and post exercise intervention) on the biceps femoris and vastus lateralis through PET imaging and hyperinsulinemic euglycemic clamp.
Measured: 24 hours
Individual steps of muscle glucose uptake (post-exercise)
Muscle glucose uptake will be assessed two times (pre and post exercise intervention) on the biceps femoris and vastus lateralis through PET imaging and hyperinsulinemic euglycemic clamp.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start30 Mar 2021
- Primary completion15 Aug 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-site, pre-post design pilot study with no control group.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bret Goodpaster, PhD, Principal investigator, Scientific Director | Senior Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754581
- Sponsor's protocol ID
- 1581803
- Acronym
- EXPET
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic in Vivo PET Imaging and ex Vivo Biopsies From Skeletal Muscle and Adipose Tissue to Investigate the Effects of Exercise on Insulin Resistance and Mitochondrial Energetics in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04754581
- Acronym / sponsor ID
- EXPET / 1581803
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Feb 2021 (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.
The overall aim of this pilot study is to investigate the effects of exercise training on skeletal muscle and adipose tissue insulin resistance in subjects with Type 2 Diabetes (T2D).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-site, pre-post design pilot study with no control group.
| Arm | Type | Receives |
|---|---|---|
| All Participants | Other | Other: Maximal ATP Production (ATPmax), Other: Exercise Testing (VO2max), Procedure: Muscle Biopsy, Procedure: Adipose Tissue Biopsy, Other: Hyperinsulinemic euglycemic clamp, Other: PET imaging |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 30-65 years
- Men and women
- Body mass index (BMI) between 25 and 45 kg/m2
- Sedentary (1 day or less per week of structured exercise)
- Type 2 diabetes mellitus determined by self-report or by a fasting glucose >126mg/dl
Key exclusion criteria (28 listed)
- Currently taking insulin, injectable incretin mimetics and thiazolidinediones
- Taking more than two glucose-lowering medications
- Resting blood pressure ≥ 160/100 mm Hg
- Triglycerides ≥ 500 mg/dL
- Any renal, cardiac, liver, lung, or neurological disease that in the opinion of the principal investigator would compromise participant safety or the participants' ability to complete the exercise training protocol
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 |
|---|---|---|
| Maximal ATP Production (ATPmax)ATPmax will be measured in order to determine in vivo mitochondrial capacity. The magnetic resonance scans to measure mitochondrial energetics will also be performed. | Other | All Participants |
| Exercise Testing (VO2max)Aerobic fitness level will be assessed while participant pedals on a stationary bicycle/walk on a treadmill. The volume of oxygen intake and carbon dioxide (CO2) production will be measured. | Other | All Participants |
| Muscle BiopsySample muscle cells from the left leg Vastus Lateralis (thigh) muscle. | Procedure or surgery | All Participants |
| Adipose Tissue BiopsySample fat tissue from the abdomen. | Procedure or surgery | All Participants |
| Hyperinsulinemic euglycemic clampMeasurement of insulin sensitivity. | Other | All Participants |
| PET imagingAfter an overnight fast, an intravenous catheter will be placed in each arm (one with arterial line for PET infusion, and the other for infusion of insulin, glucose, and 6,6 D2 glucose tracer. FDG-glucose will be injected followed by 90-minute PET scanning of the thigh. | Other | All Participants |
Primary outcome
Individual steps of muscle glucose uptake (pre-exercise)
Time frame: 24 hours
Muscle glucose uptake will be assessed two times (pre and post exercise intervention) on the biceps femoris and vastus lateralis through PET imaging and hyperinsulinemic euglycemic clamp.
Individual steps of muscle glucose uptake (post-exercise)
Time frame: 24 hours
Muscle glucose uptake will be assessed two times (pre and post exercise intervention) on the biceps femoris and vastus lateralis through PET imaging and hyperinsulinemic euglycemic clamp.
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 30 Mar 2026.
- Website for AdventHealth Translational Research InstituteLink provided by the sponsor.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Bret Goodpaster, PhD principal investigator
Scientific Director | Senior Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal ATP Production (ATPmax), Exercise Testing (VO2max) and Muscle Biopsy in people with Type 2 Diabetes, run by AdventHealth Translational Research Institute 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 28 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 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?
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?
Individual steps of muscle glucose uptake (pre-exercise) (time frame: 24 hours). 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?
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 30 Mar 2026.