CLINICAL TRIAL

High-Fruit Diet for Diabetes Mellitus, Type 2

Recruiting · 18+ · All Sexes · Birmingham, AL

Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes

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About the trial for Diabetes Mellitus, Type 2

Eligible Conditions
Diabetes Mellitus, Type 2 · Diabetes Mellitus

Treatment Groups

This trial involves 2 different treatments. High-Fruit Diet is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
High-Fruit Diet
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
HbA1c between 6.0-9.5%%
People aged between 20 and 65 years old. show original
A BMI between 27.0-45.0 kg/m^2 is considered overweight. show original
The person has been diagnosed with type 2 diabetes within the past 6 years. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
Screening: ~3 weeks
Treatment: Varies
Reporting: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether High-Fruit Diet will improve 14 primary outcomes, 6 secondary outcomes, and 21 other outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of Week 12.

Intervention satisfaction and feedback
WEEK 12
As measured by qualitative exit interview
WEEK 12
Gut microbiome diversity
CHANGE FROM BASELINE TO WEEKS 4 AND 12
Diversity metrics (i.e., alpha and beta diversity)
CHANGE FROM BASELINE TO WEEKS 4 AND 12
Depression
CHANGE FROM BASELINE TO WEEKS 4 AND 12
As measured on a 0-27 point scale by the Patient Health Questionnaire-9
CHANGE FROM BASELINE TO WEEKS 4 AND 12
Transcriptome
CHANGE FROM BASELINE TO WEEKS 4 AND 12
Fold change in gene expression within blood cells (includes pathway analyses)
CHANGE FROM BASELINE TO WEEKS 4 AND 12
Visceral fat
CHANGE FROM BASELINE TO WEEKS 4 AND 12
kg as measured using MRI
CHANGE FROM BASELINE TO WEEKS 4 AND 12
Beta-cell function
CHANGE FROM BASELINE TO WEEKS 4 AND 12
Insulinogenic index as measured during the first 15 minutes of a 3-hour OGTT
CHANGE FROM BASELINE TO WEEKS 4 AND 12
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Who is running the study

Principal Investigator
C. M. P.
Prof. Courtney M Peterson, Assistant Professor
University of Alabama at Birmingham

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is high-fruit diet safe for people?

With further study, it is possible that high-fruit diet interventions could be helpful against other chronic conditions. In general, a high-fruit diet is not a suitable primary dietary therapy option for this population.

Anonymous Patient Answer

How many people get diabetes mellitus, type 2 a year in the United States?

About 30 million new cases of [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) are diagnosed each year. This makes type 2 diabetes the most common cause of acquired, non-insulin-dependent diabetes mellitus in the US.

Anonymous Patient Answer

What are common treatments for diabetes mellitus, type 2?

Treatment for diabetes mellitus type 2 includes a large array of medications and techniques for both prevention and management. At times, patients must make important decisions regarding treatment choices.

Anonymous Patient Answer

Can diabetes mellitus, type 2 be cured?

Achieving remission in uncomplicated type 2 diabetes is difficult. However, in most cases, the disease is probably under control, as indicated by the lack of symptoms in many patients. Although patients are advised to reduce blood sugars for their own good, it is generally not clear-cut that lowering or eliminating blood sugar will result in cure of the disease.

Anonymous Patient Answer

What is diabetes mellitus, type 2?

Diabetes mellitus is a well-known chronic condition characterized by chronic high blood glucose levels. In adults over 45 years of age, Type 2 diabetes is the leading cause of diabetes related disability. Among adults between 35 and 45 years of age, Type 2 diabetes is the leading cause of diabetes related disability. Diabetes is a major risk factor for heart disease and stroke. Diabetes is one of the most significant contributors to health care expenditures. It is estimated that by 2010 diabetic foot will cause approximately 30,000 amputations a year in the US. Diabetes is the major cause of some of our most common chronic diseases.  . .

Anonymous Patient Answer

What are the signs of diabetes mellitus, type 2?

People with diabetes mellitus, type 2 have an increased risk of cardiovascular disease as compared with people who have no signs of diabetes. Diabetes mellitus type 2 is one of the most important risk factors for cardiovascular disease, because the risk of the disease doubles in every 8-10 years of existence. Diabetes mellitus type 2 can also occur at an earlier age and, if left untreated, may be lethal.\n

Anonymous Patient Answer

What causes diabetes mellitus, type 2?

The majority of patients developed diabetes Mellitus, type 2 by adolescence; however, most adolescents and their parents agree that the cause of the disease is hereditary. Diabetes mellitus, type 2 is thus hereditary in a significant proportion of patients. A single susceptibility gene must account for the familial pattern of diabetes mellitus, type 2, as observed in children and their siblings. The identification of a susceptibility gene could provide a better understanding of the mechanism of diabetes mellitus, type 2.

Anonymous Patient Answer

Have there been other clinical trials involving high-fruit diet?

Results from a recent clinical trial revealed that there are few, small-sized, trials with short duration comparing high-fruit diets and the conventional diet. Therefore, a well-designed and large-scale, long-term randomized control trial comparing HF diets with other diets is recommended for evaluating the efficacy of HF diets.

Anonymous Patient Answer

What is the latest research for diabetes mellitus, type 2?

As we learned in this literature review, many people are still diagnosed with diabetes mellitus, type 2 despite having had elevated blood sugar levels for many years without any signs of complications. However, there is some research that shows some of the possible treatments or drugs for diabetes mellitus, type 2. To take a look at what studies are being conducted for diabetes mellitus, type 2 look at the following databases: PubMed, Cochrane, and Embase. For each database look for studies that mention treatments and medications for diabetes mellitus, type 2.

Anonymous Patient Answer

Does high-fruit diet improve quality of life for those with diabetes mellitus, type 2?

A high-fruit juice-fiber diet is positively associated with HRQOL even in a non-diabetic cohort, and especially for women with diabetes. The association between HRQOL and intake of vegetables and fruits suggests a possible role for high-density lipoprotein and other unknown mediators.

Anonymous Patient Answer

What is high-fruit diet?

High-fruit diet may improve or delay age-related deterioration of glucose and insulin secretion, which helps control blood glucose and reduces the risk of insulin resistance.

Anonymous Patient Answer

Is high-fruit diet typically used in combination with any other treatments?

The diet that the American dietetic Association recommends is an effective treatment for diet-treated type 2 diabetes. It should be combined with other treatments in people who require treatment to achieve further clinical improvement.

Anonymous Patient Answer
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