Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes
NCT ID: NCT04416204
Last Updated: 2024-03-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2020-08-21
2023-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Type 2 diabetes
Participants with Type 2 Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.
glycogen loading
Subjects will consume an isocaloric diet \[60% carbs, 20% protein, 20% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study.
No Glycogen Loading
Subjects will consume an isocaloric diet \[40% carbs, 20% protein, 40% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study.
Participants without diabetes
Participants with no Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.
glycogen loading
Subjects will consume an isocaloric diet \[60% carbs, 20% protein, 20% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study.
No Glycogen Loading
Subjects will consume an isocaloric diet \[40% carbs, 20% protein, 40% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study.
Interventions
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glycogen loading
Subjects will consume an isocaloric diet \[60% carbs, 20% protein, 20% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study.
No Glycogen Loading
Subjects will consume an isocaloric diet \[40% carbs, 20% protein, 40% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study.
Eligibility Criteria
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Inclusion Criteria
* BMI 20-35kg/m\^2
* Participants with type 2 diabetes:
* HbA1c less than or equal to 8.5% on lifestyle therapy or monotherapy with metformin or sulphonylureas (SU); or less than or equal to 7.5% on two oral hypoglycemic agents (Metformin and SU)
Exclusion Criteria
* Morbidities precluding participation
* Participants with type 2 diabetes:
* Therapy with insulin
* SGLT2 inhibitors
* GLP-1 based approaches
* TZDs
* Unstable diabetic retinopathy
* Microalbuminuria
* Macrovascular disease
* Medications affecting GI motility (eg., erythromycin, pramlintide)
* Upper GI disorder/surgery
* Participants without diabetes:
* Medications (except stable thyroid hormone or hormone replacement therapy) that could influence glucose tolerance
* History of diabetes mellitus in first degree family members or prior history of diabetes mellitus or gestational diabetes, or pre-diabetes
30 Years
75 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Rita Basu
Principal Investigator
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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22074
Identifier Type: -
Identifier Source: org_study_id
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