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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
Timeline
Screening 2 days
Treatment 3 months
Follow Up 3 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I am between 20 and 65 years old.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2-hour glucose tolerance
Beta-cell function
Diabetes medication usage
+11 moreSecondary outcome measures
Dosage of cardiovascular medications used
Fasting lipids
Heart rate
+3 moreOther outcome measures
Body weight
Caloric intake
Depression
+18 moreTrial 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
1,589 Previous Clinical Trials
2,280,333 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who would be the ideal candidates for this experiment?
"Eligibility for this trial requires a diagnosis of type 2 diabetes and an age range between 20 and 65. Approximately 21 applicants are being accepted into the study."
Answered by AI
Is there an age limit for individuals who can participate in this research?
"This clinical study welcomes individuals between the ages of 20 to 65. For those below 18 years old, there are 192 trials available and 1,067 for elderly patients above 65."
Answered by AI
Are there any available openings for enrollees in this clinical trial?
"Per the information posted on clinicaltrials.gov, this medical trial is seeking suitable applicants. It was initially made available to the public in September 2019 and its details were last amended in November 2022."
Answered by AI
What are the main aims of this investigation?
"Evaluating Beta-cell function will serve as the primary outcome of this trial, assessed through Change from baseline scores at Weeks 4 and 12 and Months 6, 9, and 12. Secondary outcomes include Fasting lipids (Total cholesterol/LDL Cholesterol/HDL Cholesterol/Triglycerides), Heart Rate (Beats per Minute) and Number of Cardiovascular Medications used."
Answered by AI
How many subjects are enrolled in this clinical experimentation?
"Affirmative. Per information on clinicaltrials.gov, this medical trial is actively in the recruitment phase. It was posted on September 10th 2019 and its last update was November 29th 2022 with a total of 21 patients needed from 1 site."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
Department of Nutrition Sciences, University of Alabamam at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0
Why did patients apply to this trial?
My diabetes is out of control. I've tried everything and nothing works need help.
PatientReceived 1 prior treatment
I hope to learn more about diet effects on diabetes and hope to learn how to help control my diabetes.
PatientReceived 1 prior treatment
My neuropathy is getting worse and my daily glucose levels or increasing. My current medication is not working. I need professional help.
PatientReceived 2+ prior treatments
I have type 2 diabetes and am struggling to get my blood sugar under control. Hoping to get some help with proper nutrition for people with diabetes.
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Department of Nutrition Sciences, University of Alabamam at Birmingham: < 48 hours
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