Exercise Effects on Liver Glucose Making in Type 2 Diabetes

Trial details

Who runs it

AdventHealth Translational Research Institute

Trial code

NCT06993454

Record updated

12 August 2026

Original description

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 full original descriptionShow less

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

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).

Inclusion: 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).

Exclusion: Exclusion criteria for individuals with T2D and elevated liver fat ≥5.6% Currently taking insulin, incretin mimetics, and/or thiazolidinediones; 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; 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; New onset (<3 months on a stable regime) hormone replacement therapy; Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months; Previous bariatric or other surgery for obesity; 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; Metal implants (pacemaker, aneurysm clips) based on investigator's judgment at screening; Currently taking insulin, injectable incretin mimetics, and/or thiazolidinediones; 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; 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; New onset (<3 months on a stable regime) hormone replacement therapy; Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months; Previous bariatric or other surgery for obesity; 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; Metal implants (pacemaker, aneurysm clips) based on investigator's judgment at screening; 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); 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); 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; 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); 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); 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; 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; Triglycerides ≥ 500 mg/dL; Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures; 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; Taking glucose-lowering medications; HbA1c ≥ 5.7%; pre-diabetes, type 2 diabetes, or type 1 diabetes; Triglycerides ≥ 500 mg/dL; Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures; 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; Resting blood pressure ≥ 160/100 mm Hg; Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise testing; Post- or peri-menopausal women; Partial and/or full hysterectomy (self-report); Current use of beta-adrenergic blocking agents; 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; Unable or unwilling to communicate with staff or to provide written informed consent; Resting blood pressure ≥ 160/100 mm Hg; Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise testing; Post- or peri-menopausal women; Partial and/or full hysterectomy (self-report); Current use of beta-adrenergic blocking agents; 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; Unable or unwilling to communicate with staff or to provide written informed consent.

ClinicalTrials.gov NCT06993454