Active — Not RecruitingPhase 1

Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers

United States9 participantsStarted 2023-03-16

Plain-language summary

The purpose of this study is to help us better understand how plasma ketones respond to a low-carb diet when combined with an SGLT2 inhibitor.

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, presence of cardiac pacemaker, implanted cardiac defibrillator)
✕. Diagnosis of type 1 or type 2 diabetes mellitus, or prior diabetic ketoacidosis
✕. Blood pressure \> 140/90 mm Hg
✕. Bleeding and clotting disorders
✕. Acute or chronic infection (such as TB, HIV or Hepatitis)
✕. Renal insufficiency (eGFR\<60), nephritis, or chronic kidney disease
✕. Thyroid dysfunction (suppressed TSH, elevated TSH \<10 µIU/ml if symptomatic or elevated TSH \>10 µIU/ml if asymptomatic)
✕. Liver disease (liver function tests \> 2 x normal; including NASH/NAFLD)

Fasting ketones

Timeframe: 28 days

NCT IDNCT05662865

SponsorAdventHealth Translational Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-23