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Completed
NCT07802275
Postprandial Glucose Kinetics After Carbohydrate Restriction
Conditions: Prediabetes, Obesity & Overweight, Diet Interventions, Carbohydrate Metabolism
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 29
Sponsor: Azienda Ospedaliero, Universitaria Pisana
Location: Laboratory of Metabolism, Nutrition and Atherosclerosis, University of Pisa Pisa PI
Summary
The goal of this study is to test whether a low-carbohydrate diet (LCD), comparred with a Mediterranean diet (MED) producing similar weight loss, differentially affects fasting and postprandial glucose metabolism in individuals with overweight and dysglycemia. The main questions it aims to answer are:
* Is oral glucose absorption delayed or reduced after chronic carbohydrate restriction?
* Is insulin sensitivity differentially affected? Participants will follow 4 weeks of LCD and 4 weeks of MED, in a random order, separated by a 4-week washout. After each intervention, participants will undergo a dual-tracer 75-g oral glucose tolerance test.
Eligibility Criteria
Inclusion Criteria:
* both females and males
* age 18-65 years
* BMI 25-40 kg/m2
* impaired glucose regulation (defined as fasting plasma glucose 5.6-6.9 mmol/L, 1-h plasma glucose ≥8.6 mmol/L, 2-h plasma glucose 7.8-11.0 mmol/L, or HbA1c 39-47 mmol/mol)
Exclusion Criteria:
* Diabetes mellitus
* Chronic kidney disease
* Heart failure
* Severe liver disease
* Medications known to interfere with carbohydrate metabolism or intestinal nutrient absorption
* Metabolic surgery
Source: ClinicalTrials.gov (NCT07802275). StuddyBuddy aggregates publicly available trial information.