Type 2 DiabetesACELERATE-PNCT06993454
Acute Exercise and Endogenous Glucose Production in Type 2 Diabetes: Implications for Glycemic Control and Treatment of Hepatic Steatosis
A study testing Magnetic Resonance Liver Assessment, Bike Exercise VO2max and DEXA in people with Type 2 Diabetes and Hepatic Steatosis, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The overall aim of this study is to investigate the effects of exercise on the amount of glucose that is made by the liver in people with and without Type 2 diabetes (T2D) and hepatic steatosis (fatty liver). Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Hepatic Steatosis
- What is being tested?
- Magnetic Resonance Liver Assessment, Bike Exercise VO2max and DEXA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2025to Dec 2028
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or (pre-menopausal) female, aged 25-55 years
- Body mass index (BMI) between 18.5 and 27.5 kg/m2
- Normal liver fat (FibroScan CAP <249dB/m, <5.6% liver fat based on MRI)
- Weight stable (± 2 kg) for prior 3 months
- Active (≥3 day/week of structured exercise)
Who cannot join
- Exclusion criteria for individuals with T2D and elevated liver fat ≥5.6% Currently taking insulin, incretin mimetics, and/or thiazolidinediones
- Any change in glucose-lowering medications within the previous three months.
- Inability to stop any medications which interfere with glucose metabolism for visits 4 and 7.
- 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 protocol
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- Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)
- Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise testing
- 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 6 months
- Post- or peri-menopausal women
- Partial and/or full hysterectomy (self-report)
- Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
- Hyperthyroidism including those with normal TSH (0.35-4.5) on pharmacological treatment; individuals with hypothyroidism may be referred to their primary care provider for evaluation and retested; any medication change for hypothyroidism must be stable for ≥3 months prior to retesting
- Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures
- 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
- Previous bariatric or other surgery for obesity
- Abnormal blood count/anemia (hemoglobin <12 g/dl in men or 11 g/dl in women; Hct <34%), 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, or positive urine toxicology screen
- Alcohol consumption >7 drinks per week for women or 14 drinks per week for men or history of binge drinking (≥5 drinks for males or 4 drinks for females in a 2-hour period more than once per month)
- Metal implants (pacemaker, aneurysm clips) based on investigator's judgment at screening
- Not physically capable of performing the exercise required of the study protocols
- 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.
- Diagnosed psychotic or psychiatric conditions prohibiting adherence to study protocol; hospitalization for any psychotic or psychiatric condition within one year
- Self-reported chronic, active, or latent infection requiring chronic antibiotic or anti-viral treatment; Human Immunodeficiency Virus (HIV); active hepatitis B or C undergoing antiviral therapy
- Unable or unwilling to communicate with staff or to provide written informed consent
- Currently taking insulin, injectable incretin mimetics, and/or thiazolidinediones
- Taking glucose-lowering medications
- HbA1c ≥ 5.7%; pre-diabetes, type 2 diabetes, or type 1 diabetes
- 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 protocol
- Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)
- Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise testing
- 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
- Post- or peri-menopausal women
- Partial and/or full hysterectomy (self-report)
- Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
- Hyperthyroidism including those with normal TSH (0.35-4.5) on pharmacological treatment; individuals with hypothyroidism may be referred to their primary care provider for evaluation and retested; any medication change for hypothyroidism must be stable for ≥3 months prior to retesting
- Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures
- 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
- Previous bariatric or other surgery for obesity
- Increased liver function tests (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal)
- Abnormal blood count/anemia (hemoglobin <12 g/dl in men or 11 g/dl in women; Hct <34%), 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, or positive urine toxicology screen
- Alcohol consumption >7 drinks per week for women or 14 drinks per week for men or history of binge drinking (≥5 drinks for males or 4 drinks for females in a 2-hour period more than once per month)
- Metal implants (pacemaker, aneurysm clips) based on investigator's judgment at screening
- Not physically capable of performing the exercise required of the study protocols
- 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.
- Diagnosed psychotic or psychiatric conditions prohibiting adherence to study protocol; hospitalization for any psychotic or psychiatric condition within one year
- Self-reported chronic, active, or latent infection requiring chronic antibiotic or anti-viral treatment; Human Immunodeficiency Virus (HIV); active hepatitis B or C undergoing antiviral therapy
- Unable or unwilling to communicate with staff or to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AdventHealth Translational Research Institute
Orlando, Florida, 32804
Recruitment Department, 407-303-7100, CFD.TRI.Recruitment@AdventHealth.com
About this study
The overall aim of this study is to investigate the effects of exercise on the amount of glucose that is made by the liver in people with and without Type 2 diabetes (T2D) and hepatic steatosis (fatty liver).
- Conditions
- Type 2 Diabetes, Hepatic Steatosis
- Being tested
- Magnetic Resonance Liver Assessment, Bike Exercise VO2max, DEXA
- Medical subject headings
- Diabetes Mellitus, Type 2, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Liver AssessmentOther
Liver fat will be measured by MR imaging to assess level of hepatic steatosis.
Bike Exercise VO2maxOther
Maximal fitness measured by cycle ergometer.
DEXAOther
Measure body composition (fat and lean body mass).
| Study group | Role | What they receive |
|---|---|---|
| Lean, healthy controls | Other | Control group. Receives: Other: Magnetic Resonance Liver Assessment; Other: Bike Exercise VO2max; Other: DEXA |
| Individuals with T2D and hepatic steatosis | Other | T2D group. Receives: Other: Magnetic Resonance Liver Assessment; Other: Bike Exercise VO2max; Other: DEXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Endogenous Glucose Production (EGP)
Bulk EGP will be measured during resting and exercise conditions to determine how Endogenous Glucose Production (EGP) differs during exercise (compared to no exercise) in T2D and Metabolic dysfunction associated steatotic liver disease (MASLD).
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start25 Apr 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This research design is a cross-sectional, parallel trial with two groups: lean, healthy controls and individuals with T2D and hepatic steatosis.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine Mucinski, PhD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993454
- Sponsor's protocol ID
- 2238850
- Acronym
- ACELERATE-P
- Status last verified
- Aug 2026
- First submitted
- 11 Apr 2025
- Last updated
- 12 Aug 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Exercise and Endogenous Glucose Production in Type 2 Diabetes: Implications for Glycemic Control and Treatment of Hepatic Steatosis
- ClinicalTrials.gov ID
- NCT06993454
- Acronym / sponsor ID
- ACELERATE-P / 2238850
- Conditions
- Type 2 Diabetes, Hepatic Steatosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 May 2025 (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 study is to investigate the effects of exercise on the amount of glucose that is made by the liver in people with and without Type 2 diabetes (T2D) and hepatic steatosis (fatty liver).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research design is a cross-sectional, parallel trial with two groups: lean, healthy controls and individuals with T2D and hepatic steatosis.
| Arm | Type | Receives |
|---|---|---|
| Lean, healthy controls | Other | Other: Magnetic Resonance Liver Assessment, Other: Bike Exercise VO2max, Other: DEXAControl group. |
| Individuals with T2D and hepatic steatosis | Other | Other: Magnetic Resonance Liver Assessment, Other: Bike Exercise VO2max, Other: DEXAT2D group. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or (pre-menopausal) female, aged 25-55 years
- Body mass index (BMI) between 18.5 and 27.5 kg/m2
- Normal liver fat (FibroScan CAP <249dB/m, <5.6% liver fat based on MRI)
Key exclusion criteria (61 listed)
- Exclusion criteria for individuals with T2D and elevated liver fat ≥5.6% Currently taking insulin, incretin mimetics, and/or thiazolidinediones
- Any change in glucose-lowering medications within the previous three months.
- Inability to stop any medications which interfere with glucose metabolism for visits 4 and 7.
- Resting blood pressure ≥ 160/100 mm Hg
- Triglycerides ≥ 500 mg/dL
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 |
|---|---|---|
| Magnetic Resonance Liver AssessmentLiver fat will be measured by MR imaging to assess level of hepatic steatosis. | Other | Individuals with T2D and hepatic steatosis, Lean, healthy controls |
| Bike Exercise VO2maxMaximal fitness measured by cycle ergometer. | Other | Individuals with T2D and hepatic steatosis, Lean, healthy controls |
| DEXAMeasure body composition (fat and lean body mass). | Other | Individuals with T2D and hepatic steatosis, Lean, healthy controls |
Primary outcome
Measurement of Endogenous Glucose Production (EGP)
Time frame: Day 14
Bulk EGP will be measured during resting and exercise conditions to determine how Endogenous Glucose Production (EGP) differs during exercise (compared to no exercise) in T2D and Metabolic dysfunction associated steatotic liver disease (MASLD).
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 12 Aug 2026.
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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.
Justine Mucinski, PhD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Liver Assessment, Bike Exercise VO2max and DEXA in people with Type 2 Diabetes and Hepatic Steatosis, 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 61 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: looking for participants now, as of the sponsor's last update on 12 Aug 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?
Contact Recruitment Department (407-303-7100, CFD.TRI.Recruitment@AdventHealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Endogenous Glucose Production (EGP) (time frame: Day 14). 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 12 Aug 2026.