NCT06163248Active, not recruiting
Chrono Nutrition and Insulin Resistance in Diabetes
Effect of a Chrono Nutrition Intervention on Insulin Resistance in Adults With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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 (\<10% simple carbohydrates), 20% protein, and 40% fats (6-11% polyunsaturated, 15-20% monounsaturated, and \<10% saturated). * The plan will consist of 3 meals: breakfast will account for 40% of the total calories. Dinner will include only 10% of the total grams of carbohydrates. * The order of food consumption should be: 1) vegetables, 2) proteins, 3) complex carbohydrates, and 4) simple carbohydrates (fruits). Researchers will compare the chrono nutrition strategy with a standard dietary intervention to see the effect in insulin resistance.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 5 Oct 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Diseases
- Type 2 diabetes
- NCT number
- NCT06163248
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Jan 2024 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hospitalization in the previous three months
- Steroid treatment
Other illness
- Disease with adverse prognosis (SIDA, cancer)
- Rheumatologic diseases under immunosuppressive treatment (SLE, RA)
- Acute infection or febrile syndrome
- Other diabetes types (LADA, T1, MODY)
Lab values
- Fasting triglycerides \>500 mg/dl
Other
- Insulin treatment
- Hepatic cirrhosis
- Glomerular filtration rate \<60 ml/min
- Pregnancy
- Lactation
- High performance athletes
- Estrogen treatment
- Weight reduction \>5% in the last three months
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.