Status:
COMPLETED
Effect of a Very Low-Calorie Ketogenic Diet on Gut Microbiota and Fat Distribution
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Obesity
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
Short-term interventions that use very low-calorie ketogenic diets and meal replacements may be prescribed for selected overweight or obese patients with type 2 diabetes or prediabetes. Few, inconsist...
Detailed Description
Short-term interventions that use very low-calorie ketogenic diets and meal replacements may be prescribed for selected overweight or obese patients with type 2 diabetes or prediabetes. Few, inconsist...
Eligibility Criteria
Inclusion
- obesity (BMI 30-40)
- newly-diagnosed and untreated type 2 diabetes (fasting plasma glucose ≥ 126 mg/dL or HbA1c ≥ 6.5 mmol/L) or impaired fasting glycemia (fasting plasma glucose from 110mg/dl to 125mg/dl).
- stable body weight in the previous 3 months
Exclusion
- known hypersensitivity to one or more components used in the protocol products; history of renal, cardiac, cerebrovascular or gastrointestinal diseases; psychiatric disturbances; hydroelectrolytic alterations, diagnosis of type 1 diabetes lack of informed consent; history of or planned weight loss surgery
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04019431
Start Date
July 1 2019
End Date
November 1 2019
Last Update
May 17 2022
Active Locations (1)
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1
Sapienza University of Rome
Roma, RM, Italy, 00161