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Active Not Recruiting NCT06163248

Chrono Nutrition and Insulin Resistance in Diabetes

Conditions: Diabetes Mellitus, Type 2

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Location: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City Mexico City

Summary

The goal of this randomized clinical trial is to determine the effect of a chrono nutrition intervention compared with a usual dietary intervention on insulin resistance in individuals with type 2 diabetes with overweight or obesity over a 6-month period. The main question it aims to answer is: What is the effect of a chrono nutrition intervention compared to a standard intervention on insulin resistance in individuals with T2D (type 2 diabetes) with overweight or obesity over a 6-month period? Participants: * Will be asked to fast for 12 hours each day. During the fasting period, they may consume non-caloric beverages such as plain water, coffee, or unsweetened tea. * They will be asked to follow a dietary plan in which the total daily calorie intake will be calculated using indirect calorimetry, subtracting 500 calories from the total calorie amount. * The dietary plan will have the following macronutrient distribution: 40% carbohydrates (\

Eligibility Criteria

Inclusion Criteria: * Patients diagnosed with type 2 diabetes (T2D) * HbA1c \< 8.5% * BMI ≥ 25 kg/m2 and \< 35 kg/m2 * Stable pharmacological treatment for the last 3 months * Willingness to participate in the protocol. Exclusion Criteria: * Insulin treatment * Hospitalization in the previous three months * Disease with adverse prognosis (SIDA, cancer) * Rheumatologic diseases under immunosuppressive treatment (SLE, RA) * Acute infection or febrile syndrome * Hepatic cirrhosis * Glomerular filtration rate \500 mg/dl * Pregnancy * Lactation * Steroid treatment * High performance athletes * Estrogen treatment * Weight reduction \>5% in the last three months

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06163248). StuddyBuddy aggregates publicly available trial information.