Status:
COMPLETED
Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03758742
Start Date
September 10 2019
End Date
September 5 2023
Last Update
June 10 2025
Active Locations (1)
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1
Department of Nutrition Sciences, University of Alabamam at Birmingham
Birmingham, Alabama, United States, 35233