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NCT06735859 | RECRUITING | Type 2 Diabetes Mellitus (T2DM)

Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss
Sponsor:

Federal University of São Paulo

Information provided by (Responsible Party):

Luciana Pellegrini Pisani

Brief Summary:

This project aims to offer a quantitative and qualitative nutritional approach, along with educational nutritional guidelines for participants with Non-Communicable Chronic Diseases. The main goals are: 1- Regularization of eating habits and windows; 2- Modulation of biochemical, anthropometric, and cardiovascular parameters; 3- Increase in knowledge about healthy eating. In this way, participants will undergo a complete nutritional assessment, comprising anthropometry, biochemistry, clinical, and dietary evaluations.

Condition or disease

Type 2 Diabetes Mellitus (T2DM)

Hypertension

Obesity and Type 2 Diabetes

Cardiovascular Diseases

Intervention/treatment

Comparison of eating windows intervention

Phase

NA

Detailed Description:

The study will be conducted at the Endocrinology and Hypertension Clinic of the São José do Rio Preto Medical School from 2025 to 2027, aiming to collect data for a thorough analysis of the participants. The study participants will be randomly assigned to 2 groups (intervention 1 and intervention 2). Participants in the first group will follow a daytime eating window (7 am - 7 pm). Participants in the second group will follow a nighttime eating window (12 pm - 12 am). Nutritional consultations will be individual and will occur once every 3 months until the conclusion of the study, according to the clinic's scheduling availability. The average duration of each session will be approximately 1 hour per participant. All participants will be reminded of their appointments via phone/WhatsApp.

Study Type : INTERVENTIONAL
Estimated Enrollment : 48 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Impact of Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss in Chronic Diseases
Actual Study Start Date : 2025-11
Estimated Primary Completion Date : 2027-11-19
Estimated Study Completion Date : 2027-11-19

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age: Adults \>18 years \< 80 years; Diagnosis of obesity, diabetes, and hypertension; Gender: Male and female; Availability to attend quarterly meetings over a period of 18 months; Sedentary.
Exclusion Criteria
  • * Difficulties in responding to the requested instruments; Impediments to regular attendance in data collection; No diagnosis of Obesity, Diabetes, and Hypertension; Use of insulin therapy, Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors, and Glucagon-Like Peptide-1 (GLP-1) analogs; Chronic Kidney Disease patients; Normal weight or undernourished individuals; Physical exercise practitioners (\>150 minutes of exercise/week).
Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss

Location Details

NCT06735859

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Brazil, São Paulo

Federal University of São Paulo (UNIFESP)

Santos, São Paulo, Brazil, 11065-200