Low-Carb Diet + SGLT2 Inhibitor for Ketosis Management

(CASINO Trial)

Overseen By Recruitment Department

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AdventHealth Translational Research Institute

Must be taking: SGLT2 inhibitors

Must not be taking: Psychiatric medications, Anti-diabetic agents

Disqualifiers: Cardiovascular disease, Diabetes, Hypertension, Infection, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that may influence metabolism, anti-diabetic agents, blood thinners, and chronic use of aspirin or other non-steroidal anti-inflammatory drugs. If you have recently changed your medication or dosage in the past 3 months, you may also be excluded.

Is it safe to combine a low-carb diet with SGLT2 inhibitors?

Combining a low-carb diet with SGLT2 inhibitors can lead to a rare but serious condition called euglycemic diabetic ketoacidosis (EDKA), where the body produces high levels of acids called ketones. This risk is higher if you reduce your carbohydrate intake significantly, so it's important to have medical guidance when using these treatments together. ^{1 2 3 4 5}

How is the Low-Carb Diet + SGLT2 Inhibitor treatment different from other treatments for ketosis management?

This treatment is unique because it combines a low-carbohydrate diet with SGLT2 inhibitors, which are drugs that help lower blood sugar by causing the kidneys to remove sugar through urine. However, this combination can increase the risk of a rare condition called euglycemic diabetic ketoacidosis (EDKA), where the body produces high levels of acids called ketones, even when blood sugar levels are not very high. ^{1 2 5 6 7}

What data supports the effectiveness of this treatment?

The research highlights potential risks rather than effectiveness, showing that combining a low-carb diet with SGLT2 inhibitors can lead to a serious condition called euglycemic diabetic ketoacidosis (EDKA), especially in people with diabetes. ^{1 2 4 7 8}

Who Is on the Research Team?

Melissa Erickson, PhD

Principal Investigator

AdventHealth Translational Research Institute

Are You a Good Fit for This Trial?

Healthy volunteers aged 18-60 with a BMI of 21-35 kg/m2, who have been weight stable and are willing to follow the study's diet and procedures. Excluded are those with high blood pressure, liver disease, drug use, eating disorders, certain medical or psychiatric conditions, recent blood donation or medication changes that affect metabolism.

Inclusion Criteria

I am either male or female.

Willing and able to comply with scheduled visits, laboratory tests, and other study procedures

Otherwise healthy, as determined by medical history and laboratory tests

Exclusion Criteria

I am taking medication for diabetes.

I don't have health issues or take medications that would interfere with the study.

I have a condition that affects my blood's ability to clot or causes bleeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an SGLT2 inhibitor combined with a low-carbohydrate adaptive diet to achieve moderate ketosis

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low-Carbohydrate Diet
• SGLT2 inhibitor

Trial Overview The trial is exploring how a low-carbohydrate diet paired with an SGLT2 inhibitor affects ketone levels in the blood. Participants will adapt to this controlled diet to induce moderate ketosis under close observation.

How Is the Trial Designed?

Group I: Single, Experimental Group Experimental Treatment 2 Interventions

SGLT2i + adaptive study diet of progressive dietary carbohydrate reduction

Who Is Running the Clinical Trial?

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Euglycemic diabetic ketoacidosis in a patient with type 2 diabetes mellitus 3 days after initiating sodium-glucose cotransporter 2 inhibitor while on an extremely low carbohydrate diet: A case report. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Dietary Changes Leading to Euglycemic Diabetic Ketoacidosis in Sodium-Glucose Cotransporter-2 Inhibitor Users: A Challenge for Primary Care Physicians? [2022]

3. Sweden pubmed.ncbi.nlm.nih.gov

[Life-threatening ketoacidosis in patients with type 2 diabetes on LCHF diet]. [2019]

4. Japan pubmed.ncbi.nlm.nih.gov

Case of ketoacidosis by a sodium-glucose cotransporter 2 inhibitor in a diabetic patient with a low-carbohydrate diet. [2022]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

A Case Report: Euglycemic Diabetic Ketoacidosis Presenting as Chest Pain in a Patient on a Low Carbohydrate Diet. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The DKA that wasn't: a case of euglycemic diabetic ketoacidosis due to empagliflozin. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Euglycemic Diabetic Ketoacidosis Caused by SGLT2 Inhibitors and a Ketogenic Diet: A Case Series and Review of Literature. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse Drug Reaction Profile of SGLT2 Inhibitor-Associated Diabetic Ketosis/Ketoacidosis in Singapore and their Precipitating Factors. [2021]