Clinical trial for Type1diabetes
Official title Effects of Ketosis on Brain Function in Patients With T1DM
ClinicalTrials.gov ID: NCT04219709
What this study is testing
- What it's testing
- This study is testing whether a ketogenic diet helps the brain handle low blood sugar. It looks at how this diet affects thinking and brain health.
- Who it's for
- You may be able to join if you have type 1 diabetes.
- What's involved
- You would follow a very low-carb diet. The team will check your blood sugar and brain function.
- Time commitment
- The source text does not say how long the study lasts or what visits are needed.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join if
- Males and females with T1D for at least 1 year
- Age 18 to 40 years
- Tanner stage ≥ IV
- BMI 18.5-35 kg/m2
- Stable glycemic control (HbA1c 6.5-9%)
You likely can't join if
- Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months
- Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g.
- Following a weight-loss or otherwise restrictive diet
- Vigorous exercise \>2 hours on \>3 days a week
- History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
- Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables
See the full eligibility criteria
- Males and females with T1D for at least 1 year
- Age 18 to 40 years
- Tanner stage ≥ IV
- BMI 18.5-35 kg/m2
- Stable glycemic control (HbA1c 6.5-9%)
- Use of a continuous glucose monitor (CGM)
- Use of an insulin pump
- Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)
- Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months
- Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies
- Following a weight-loss or otherwise restrictive diet
- Vigorous exercise \>2 hours on \>3 days a week
- History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
- Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables
- Significant psychiatric illness
- Smoking, use of recreational drugs, or excessive alcohol consumption
- Pregnancy or breastfeeding
- Anemia
- Standard MRI exclusion criteria
- Irregular menses
- Use of psychotropic medication other than SSRIs or other mild antidepressant or anxiety medications (unless these medications are safe to be held for several days to allow for the acquisition of MRI data).
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.