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Low-Carb Diet + SGLT2 Inhibitor for Ketosis Management (CASINO Trial)

Phase 1
Recruiting
Led By Melissa Erickson, PhD
Research Sponsored by AdventHealth Translational Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-60 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

CASINO Trial Summary

This trial tests how a low-carb diet + a diabetes drug affects blood ketones, which can help people manage diabetes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include changes in blood pressure due to the low-carb diet or dehydration and possible kidney issues from the SGLT2 inhibitor. Specific side effects will be monitored closely throughout the study.

CASINO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 60 years old.

CASINO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fasting ketones
Secondary outcome measures
24h AUC plasma ketones

CASINO Trial Design

1Treatment groups
Experimental Treatment
Group I: Single, Experimental GroupExperimental Treatment2 Interventions
SGLT2i + adaptive study diet of progressive dietary carbohydrate reduction
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SGLT2 inhibitor
2019
Completed Phase 3
~17850

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
20,173 Total Patients Enrolled
Melissa Erickson, PhDPrincipal InvestigatorAdventHealth Translational Research Institute
1 Previous Clinical Trials
45 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age of 50 serve as an exclusionary factor for this research project?

"Patents must be between the age of 18 and 60 in order to join this clinical trial. For those below 18, a separate 1-trial is available; while 22 trials are offered for elderly people exceeding 65 years old."

Answered by AI

To which patient demographic is this medical experiment open?

"For eligibility in this trial, prospective participants must have ketosis and fit within the age range of 18 to 60. This medical study is aiming to recruit 8 individuals."

Answered by AI

Is Group 2 a risk-free option for individuals?

"Group 2 has a safety rating of 1 on our scale, due to the limited data currently available from this Phase 1 trial."

Answered by AI

To what extent has recruitment been successful for this research effort?

"Affirmative. Clinicaltrials.gov indicates that recruitment for this experiment is ongoing; the trial was first published on 1st March 2023 and subsequently updated on 27th March 2023. The research requires 8 participants at a single site."

Answered by AI

Is enrollment currently available for this experiment?

"Affirmative. According to clinicaltrials.gov, this medical experiment was initially posted March 1st 2023 and has recently been updated on the 27th of that month. Eight participants are necessary for its completion at a single testing site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers
2023. "Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05662865.
~1 spots leftby Jun 2024
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