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Low Carb Diet for Type 1 Diabetes
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1 week
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I am between 18 and 60 years old.
Select...
I weigh at least 110 pounds.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in endothelial function - diet 1
Change in endothelial function - diet 2
Change in insulin sensitivity - diet 1
+1 moreTrial 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
856 Previous Clinical Trials
672,152 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been recruited into this clinical research effort?
"Affirmative. According to clinicaltrials.gov, this experiment is still recruiting patients who responded to the call-out first posted on March 29th 2019 and modified October 6th 2022. The research team seeks 40 individuals from two different trial locations."
Answered by AI
Is enrollment available for individuals below the age of 85 in this clinical trial?
"This trial is open to patients between the age of majority and 60 years old."
Answered by AI
Who is eligible to partake in the ongoing research project?
"This medical trial seeks 40 volunteers who suffer from diabetes and an autoimmune disease, with ages ranging between 18 and 60. To be considered for participation, applicants must meet certain prerequisites: An HbA1c score of 5.6 to 9%, insulin pump users only, body mass index greater than or equal to 50kg (110lbs), BMI of 18-33 kg/m^2 , and use a continuous glucose monitor (CGM)."
Answered by AI
Are applications for this clinical experiment still being accepted?
"This study is still seeking participants. The initial announcement was released on March 29th 2019, and the listing had been recently updated as of October 6th 2022 according to clinicaltrials.gov."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What portion of applicants met pre-screening criteria?
Met criteria
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