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

The University of Alabama at Birmingham

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Behavioral: High-Fruit Diet

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03758742

P30DK079626 (U.S. NIH Grant/Contract)

IRB-300001719

Details and patient eligibility

About

Diabetes costs the U.S. healthcare system more than any other disease, and nearly half of Americans will develop either diabetes or prediabetes in their lifetime. It is therefore critical to find new strategies to treat or reverse diabetes.

One such approach is adopting a healthy diet, which can dramatically improve blood sugar levels in adults with type 2 diabetes and even induce diabetes remission. Despite this, not much is known about which food groups are most effective at improving blood sugar levels in patients with diabetes.

Interestingly, of the various food groups, epidemiologic data suggests that whole fruit may be one of the most efficacious at both preventing type 2 diabetes and improving blood sugar in patients with type 2 diabetes. However, few clinical trials have investigated the effects of whole fruit on blood sugar control. This study will therefore be the first to determine the effects of increasing whole fruit as a food group in type 2 diabetes patients. This supervised controlled feeding trial will test whether consuming a diet rich in whole fruit for 12 weeks can improve glycemic control and cardiometabolic health in weight-stable adults with type 2 diabetes. The primary endpoint is glycemic control. Since changes in medication doses can skew the interpretation of glycemic outcomes, glycemic control will be assessed hierarchically (in descending order of importance) using (a) attainment of nondiabetic glycemia without medications (as a proxy for diabetes remission), (b) medication effect scores, (c) mean glucose during an oral glucose tolerance test, and (d) 24-hour mean glucose from continuous glucose monitoring. As secondary aims, this study will also test whether consuming a large amount of fructose in whole food form affects liver fat, pancreatic fat, and cardiovascular disease risk factors.

Enrollment

34 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

20-70 years old
BMI ≤45.0 kg/m^2
First diagnosed with type 2 diabetes within the past 6 years
HbA1c between 6.0-9.5%%

Exclusion criteria

On insulin
Diagnosis of diabetes before age 18
Estimated glomerular filtration rate < 45 ml/min per 1.732 m^2
Heart attack in the past 6 months or severe or unstable heart failure
On weight loss medication
Change in the dosage of a chronic medication that may affect study endpoints within the past 3 months
Clinically significant laboratory abnormality (e.g. abnormal hemoglobin levels)
Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise safety or data validity
Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
Lost or gained more than 5 kg of weight in the past 6 months
Pregnant, planning to become pregnant in the next 12 months, or breastfeeding
Major psychiatric condition that would affect the ability to participate in the study
Not able to eat the provided study meals
Behavioral factors or circumstances that may impede adhering to the dietary intervention
Not able to do the MRI/MRS abdominal scan, such as due to claustrophobia, implanted metal objects, or a body girth of 60 cm or greater