Effects of low-carbohydrate diets in the treatment of chronic diseases

Not Applicable

Recruiting

• Conditions: Type 1 diabetes Mellitus; Low-carbohydrate diet; Glycemic control; Glycated Hemoglobin; Dietary therapy; C18.452.394.750

• Registration Number: RBR-107jk4tn
• Lead Sponsor: Amanda Aparecida Felizardo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-03
• Study Completion: 2023-02-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Have a diagnosis of type 1 diabetes Mellitus; present from 21 to 50 years of age of both sexes; have glycated hemoglobin (Hb1Ac) >7.0%; agree to follow all parameters considered in the protocol for the treatment of type 1 diabetes with a low-carbohydrate diet; belong to any region of the country; have creatinine clearance < 60; use a glucometer or sensor (Libre, Flash Glucose Monitoring) for minimum of 7 measurements per day; perform a fundus examination for the diagnosis of diabetic retinopathy; have mild retinopathy treated (to be evaluated by the ophthalmologist and endocrinologist); be willing to consume, during the first 15 days of the protocol, the amount of 130g of daily carbohydrates; sign the authorization to participate in the research through the Informed Consent Form (TCLE); agree to perform all laboratory tests before starting the survey, three months after the start of the 50g daily carbohydrate phase, and at the end of the sixth month of the survey.

Exclusion Criteria

Have moderate to advanced diabetic retinopathy (to be evaluated by the ophthalmologist and endocrinologist); present reports or suspicion of gastroparesis; have an eating disorder, such as binge eating; be an athlete; use an insulin pump; have a pregnancy diagnosis.

Study & Design

• Study Type: Intervention
• Study Design: Not specified