Clinical trial NCT06735859: Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss
Official title: Impact of Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss in Chronic Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Hypertension
Obesity and Type 2 Diabetes
Cardiovascular Diseases
Keywords: type 2 diabetes
hypertension
obesity
cardiovascular diseases
nutritional intervention
sleep
eating window
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Sao Jose do Rio Preto Medical School
First posted: 2024-12-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a randomized, crossover clinical trial with a washout period and follow-up.
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Weight (Kg)
timeFrame: From registration to end of 30-month treatment (2027)
measure: HbA1c (%)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Total cholesterol (TC) (mg/dL)
timeFrame: From registration to end of 30-month treatment (2027)
measure: LDL cholesterol (mg/dL)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Height (meters)
timeFrame: From registration to end of 30-month treatment (2027)
measure: BMI (Body Mass Index - Kg/m²)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Waist circumference (cm)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Waist/hip ratio
timeFrame: From registration to end of 30-month treatment (2027)
measure: Body Shape Index (ABSI)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Blood pressure (BP) (mmHg)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Skipping breakfast
timeFrame: From registration to end of 30-month treatment (2027)
measure: Dietary assessment (habitual food recall)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Sociodemographic assessment:
timeFrame: From registration to end of 30-month treatment (2027)
measure: Lean mass (kg)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Body fat percentage (%)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Plasma glucose (mg/dL)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Triglycerides (TG) (mg/dL)
timeFrame: From registration to end of 30-month treatment (2027)
measure: HDL cholesterol (mg/dL)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Hip circumference (cm)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Neck circumference (cm)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Hip Index (HI)
timeFrame: From registration to end of 30-month treatment (2027)
measure: Physical exercise
timeFrame: From registration to end of 30-month treatment (2027)
measure: Medications
timeFrame: From registration to end of 30-month treatment (2027)
Secondary outcomes:
Other outcomes:
Locations:
city: Santos
country: Brazil
facility: Federal University of São Paulo (UNIFESP)
state: São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Luciana P Pisani, PhD
role: PRINCIPAL_INVESTIGATOR
References: