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Low Carb Diet for Type 1 Diabetes
N/A
Waitlist Available
Led By Justin M Gregory, MD, MSCI
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body Mass >/= 50 kg ( 110 lbs)
Age: 18-60
Must not have
diabetes comorbidities (>= 1 trip to emergency department for poor glucose control in the past 6 months)
Additional exclusion criteria for T1DM subjects: any diabetes medication except insulin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1 week
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether reducing insulin doses and eating a low carbohydrate diet will improve insulin sensitivity and blood vessel health.
Who is the study for?
Adults aged 18-60 with Type 1 Diabetes, a BMI of 18-33, and an HbA1c level between 5.6-9.0% can join this trial if they weigh at least 50 kg (110 lbs), use an insulin pump and a continuous glucose monitor. Pregnant women, smokers, those on certain medications or diets, or with specific health conditions like severe hypoglycemia history are excluded.
What is being tested?
The study is comparing the effects of a standard carbohydrate diet versus a low carbohydrate diet on insulin sensitivity and blood vessel health in people with Type 1 Diabetes who are using insulin pumps.
What are the potential side effects?
Potential side effects may include changes in blood sugar levels due to dietary adjustments which could affect diabetes management. Specific side effects related to the diets themselves are not detailed but monitoring will be necessary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 110 pounds.
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I am between 18 and 60 years old.
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I weigh at least 110 pounds.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes and visited the ER at least once for it in the last 6 months.
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I only use insulin for my type 1 diabetes.
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My kidney function is reduced.
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My heart condition limits my physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 1 week
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in endothelial function - diet 1
Change in endothelial function - diet 2
Change in insulin sensitivity - diet 1
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard Carb Diet then Low Carb DietExperimental Treatment2 Interventions
Group II: Low Carb Diet then Standard Carb DietExperimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
900 Previous Clinical Trials
939,494 Total Patients Enrolled
Justin M Gregory, MD, MSCIPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
39 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to use a continuous glucose monitor (CGM).You are pregnant, not fully developed, going through or finished menopause, a regular smoker, or need a gluten-free diet.I have had one or more severe low blood sugar episodes in the last 3 months.I have diabetes and visited the ER at least once for it in the last 6 months.I only use insulin for my type 1 diabetes.Your body mass index (BMI) is between 18 and 33.Your HbA1c level is between 5.6% and 9.0%.Your blood pressure is higher than 140/100 mmHg.Your hematocrit level is less than 35%.I weigh at least 110 pounds.My kidney function is reduced.My heart condition limits my physical activity.I am between 18 and 60 years old.I have not taken any listed medications less than 2 weeks before the study.Your liver enzymes (AST or ALT) are more than 2.5 times the normal level.You need to be using an insulin pump to deliver insulin.I weigh at least 110 pounds.
Research Study Groups:
This trial has the following groups:- Group 1: Low Carb Diet then Standard Carb Diet
- Group 2: Standard Carb Diet then Low Carb Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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