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