Metabolism of Low Carbohydrate and Ketogenic Diet
NCT05071287 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-02-21
Summary
This study will assess the preliminary efficacy of a lifestyle intervention including low-carb/ketogenic diet and exercise, enhanced by self-monitoring through health technologies on weight and diabetes outcomes (Glucose, HbA1c) and diabetic complications (cognitive function, and renal function) in a 6-month randomized clinical trial in 60 overweight/obese adults with or without T2D. Renal function will be assessed via both traditional and novel biomarkers, including novel metabolites and mitochondrial function.
Conditions
- Diabetic Kidney Disease
- Cognitive Function
- Weight Loss
- Diabetic Control
- Type2 Diabetes
Interventions
- OTHER
-
mHealth + low-fat diet
A restricted total calorie and reduced total fat consumption.
- OTHER
-
mHealth + low-carb/ketogenic diet
A low-carb/ketogenic diet
Sponsors & Collaborators
-
The University of Texas Health Science Center at San Antonio
lead OTHER
Principal Investigators
-
Yan Du, PhD MPH RN · University of Texas Health San Antonio
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-03
- Primary Completion
- 2022-04-30
- Completion
- 2022-10-11
Countries
- United States
Study Locations
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