Acute Exercise and Endogenous Glucose Production in Type 2 Diabetes: Implications for Glycemic Control and Treatment of Hepatic Steatosis

NCT ID: NCT06993454

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-25
• Study Completion Date: 2026-03-31

Brief 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).

Conditions

Type 2 Diabetes; Hepatic Steatosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Lean, healthy controls

Control group.

Group Type: OTHER

Magnetic Resonance Liver Assessment

Intervention Type: OTHER

Liver fat will be measured by MR imaging to assess level of hepatic steatosis.

Bike Exercise VO2max

Intervention Type: OTHER

Maximal fitness measured by cycle ergometer.

DEXA

Intervention Type: OTHER

Measure body composition (fat and lean body mass).

Individuals with T2D and hepatic steatosis

T2D group.

Group Type: OTHER

Magnetic Resonance Liver Assessment

Intervention Type: OTHER

Liver fat will be measured by MR imaging to assess level of hepatic steatosis.

Bike Exercise VO2max

Intervention Type: OTHER

Maximal fitness measured by cycle ergometer.

DEXA

Intervention Type: OTHER

Measure body composition (fat and lean body mass).

Interventions

Magnetic Resonance Liver Assessment

Liver fat will be measured by MR imaging to assess level of hepatic steatosis.

Intervention Type: OTHER

Bike Exercise VO2max

Maximal fitness measured by cycle ergometer.

Intervention Type: OTHER

DEXA

Measure body composition (fat and lean body mass).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or (pre-menopausal) female, aged 25-55 years

4. Body mass index (BMI) between 25 and 45 kg/m2

5. Sedentary (1 day or less per week of structured exercise)

6. Type 2 diabetes mellitus: HbA1c ≥7.5%

7. Liver fat ≥5.6% based on MRI

8. Weight stable (± 2 kg) for prior 3 months

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or (pre-menopausal) female, aged 25-55 years

4. Body mass index (BMI) between 18.5 and 27.5 kg/m2

5. Normal liver fat (FibroScan CAP <249dB/m, <5.6% liver fat based on MRI)

6. Weight stable (± 2 kg) for prior 3 months

7. Active (≥3 day/week of structured exercise)

Exclusion Criteria

2. Any change in glucose-lowering medications within the previous three months.

3. Inability to stop any medications which interfere with glucose metabolism for visits 4 and 7.

4. Resting blood pressure ≥ 160/100 mm Hg

5. Triglycerides ≥ 500 mg/dL

6. 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

7. Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)

8. Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise testing

9. Cancer (active malignancy with or without concurrent chemotherapy; except for basal cell carcinoma)

10. Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next 6 months

11. Post- or peri-menopausal women

12. Partial and/or full hysterectomy (self-report)

13. Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc

14. 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

15. Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures

16. New onset (<3 months on a stable regime) hormone replacement therapy

17. Current use of beta-adrenergic blocking agents

18. Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months

19. Previous bariatric or other surgery for obesity

20. 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

21. Current smokers (smoking within the past 3 months prior to screening visit, including any/all tobacco products)

22. Current drug or alcohol abuse/dependence, or positive urine toxicology screen

23. 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)

24. Metal implants (pacemaker, aneurysm clips) based on investigator's judgment at screening

25. Not physically capable of performing the exercise required of the study protocols

26. 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.

27. Unable to tolerate MRI or claustrophobia.

28. Diagnosed psychotic or psychiatric conditions prohibiting adherence to study protocol; hospitalization for any psychotic or psychiatric condition within one year

29. 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

30. Unable or unwilling to communicate with staff or to provide written informed consent

1. Currently taking insulin, injectable incretin mimetics, and/or thiazolidinediones

2. Taking glucose-lowering medications

3. HbA1c ≥ 5.7%; pre-diabetes, type 2 diabetes, or type 1 diabetes

4. Resting blood pressure ≥ 160/100 mm Hg

5. Triglycerides ≥ 500 mg/dL

6. 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

7. Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)

8. Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise testing

9. Cancer (active malignancy with or without concurrent chemotherapy; except for basal cell carcinoma)

10. Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next year

11. Post- or peri-menopausal women

12. Partial and/or full hysterectomy (self-report)

13. Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc

14. 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

15. Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures

16. New onset (<3 months on a stable regime) hormone replacement therapy

17. Current use of beta-adrenergic blocking agents

18. Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months

19. Previous bariatric or other surgery for obesity

20. Increased liver function tests (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal)

21. 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

22. Current smokers (smoking within the past 3 months prior to screening visit, including any/all tobacco products)

23. Current drug or alcohol abuse/dependence, or positive urine toxicology screen

24. 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)

25. Metal implants (pacemaker, aneurysm clips) based on investigator's judgment at screening

26. Not physically capable of performing the exercise required of the study protocols

27. 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.

28. Unable to tolerate MRI or claustrophobia.

29. Diagnosed psychotic or psychiatric conditions prohibiting adherence to study protocol; hospitalization for any psychotic or psychiatric condition within one year

30. 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

31. Unable or unwilling to communicate with staff or to provide written informed consent

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AdventHealth Translational Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justine Mucinski, PhD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

AdventHealth Translational Research Institute

Orlando, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Recruitment Department

Role: CONTACT

CFD.TRI.Recruitment@AdventHealth.com

407-303-7100

Facility Contacts

Recruitment Department

Role: primary

CFD.TRI.Recruitment@AdventHealth.com

407-303-7100

Other Identifiers

2238850

Identifier Type: -

Identifier Source: org_study_id