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High-Fruit Diet for Type 2 Diabetes
N/A
Recruiting
Led By Courtney M. Peterson, Ph.D.
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
20-65 years old
20-65 years old
Must not have
On insulin
Diagnosis of diabetes before age 18
Timeline
Screening 2 days
Treatment 3 months
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether consuming a diet rich in whole fruit for 12 weeks can induce diabetes remission and improve blood sugar, liver fat, and cardiovascular health in adults with type 2 diabetes.
Who is the study for?
Adults aged 20-65 with type 2 diabetes, diagnosed in the last 6 years and having an HbA1c level of 6.0-9.5%, can join this trial if they have a BMI between 27.0-45.0 kg/m^2 and are not on insulin or weight loss medication, pregnant, or have significant health issues that could interfere with the study.
What is being tested?
The trial is testing whether a high-fruit diet over a period of 12 weeks can help adults with type 2 diabetes improve their blood sugar control and possibly achieve diabetes remission while also looking at effects on liver fat and heart health.
What are the potential side effects?
While specific side effects are not listed for eating whole fruit, potential concerns may include digestive changes due to increased fiber intake or unexpected impacts on blood sugar levels which will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 20 and 65 years old.
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I am between 20 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking insulin.
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I was diagnosed with diabetes before I turned 18.
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I have had a heart attack in the last 6 months or suffer from severe heart failure.
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I am currently taking medication for weight loss.
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I have serious stomach or intestine problems, had major surgery on them, or have gallstones.
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I have lost or gained more than 5 kg in the last 6 months.
Timeline
Screening ~ 2 days2 visits
Treatment ~ 3 months14 visits
Follow Up ~ 3 months1 visit
Screening ~ 2 days
Treatment ~ 3 months
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
2-hour glucose tolerance
Beta-cell function
Diabetes medication usage
+11 moreSecondary study objectives
Dosage of cardiovascular medications used
Fasting lipids
Heart rate
+3 moreOther study objectives
Body weight
Caloric intake
Depression
+18 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: High-Fruit DietExperimental Treatment1 Intervention
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,695 Total Patients Enrolled
Courtney M. Peterson, Ph.D.Principal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
144 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is between 27.0 and 45.0 kg/m^2.I do not have major heart, kidney, liver, lung, adrenal gland, or nervous system diseases.You have habits or situations that may make it difficult for you to follow the study's required diet.I am currently taking insulin.I have had a heart attack in the last 6 months or suffer from severe heart failure.HbA1c between 6.0-9.5% is considered a 'high risk' for developing diabetes.You have a serious mental illness that may make it difficult for you to take part in the study.My chronic medication dose hasn't changed in the last 3 months.I have serious stomach or intestine problems, had major surgery on them, or have gallstones.I am between 20 and 65 years old.I am between 20 and 65 years old.I have had cancer other than non-melanoma skin cancer in the last 5 years.I was diagnosed with type 2 diabetes in the last 6 years.I have lost or gained more than 5 kg in the last 6 months.I am currently taking medication for weight loss.I was diagnosed with type 2 diabetes in the last 6 years.I was diagnosed with diabetes before I turned 18.You have a body mass index (BMI) between 27.0 to 45.0 kg/m^2.
Research Study Groups:
This trial has the following groups:- Group 1: High-Fruit 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 2 Days to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT03758742 — N/A
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