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

NCT06993454 | Recruiting

• 1 other identifier: 2238850
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 14

Study Arms (2)

Lean, healthy controls

OTHER

Control group.

Other: Magnetic Resonance Liver Assessment; Other: Bike Exercise VO2max; Other: DEXA

Individuals with T2D and hepatic steatosis

OTHER

T2D group.

Other: Magnetic Resonance Liver Assessment; Other: Bike Exercise VO2max; Other: DEXA

Interventions

Magnetic Resonance Liver Assessment OTHER

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

Individuals with T2D and hepatic steatosis; Lean, healthy controls

Bike Exercise VO2max OTHER

Maximal fitness measured by cycle ergometer.

Individuals with T2D and hepatic steatosis; Lean, healthy controls

DEXA OTHER

Measure body composition (fat and lean body mass).

Individuals with T2D and hepatic steatosis; Lean, healthy controls

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 25 and 45 kg/m2
• Sedentary (1 day or less per week of structured exercise)
• Type 2 diabetes mellitus: HbA1c ≥7.5%
• Liver fat ≥5.6% based on MRI
• Weight stable (± 2 kg) for prior 3 months
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Fatty Liver

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Justine Mucinski, PhD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Recruitment Department

CONTACT

407-303-7100; CFD.TRI.Recruitment@AdventHealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This research design is a cross-sectional, parallel trial with two groups: lean, healthy controls and individuals with T2D and hepatic steatosis.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 28, 2025
• Study Start: April 25, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)