Glycemic Variability Comparing Two vs Five Meals in Type 2 Diabetes

Effect on Glycemic Variability, Weight and Oxidative Stress Markers FGF 21 in a Low Calorie Diet of Three Meals Compared With a Conventional Low Calorie Plan of Five Meals in Patients With Type 2 Diabetes With Overweight or Obesity

The frequency of meals is a very important aspect of nutrition, with profound effects on human health and in life expectancy. Excessive energy consumption is totally associated with a significant increase in the incidence of chronic diseases including diabetes. That is why nutritional therapy is recommended for all people with diabetes mellitus type 1 and 2 as an effective complement to your medical treatment. For overweight or obese type 2 diabetic patients, a low-calorie diet along with healthy eating patterns are recommended for weight loss. Similarly, modest body weight decrease may provide clinical benefits in patients, such as improved blood glucose, blood pressure, lipid profile, and others. Data about the role of nutritional habits and energy density being important precursors of obesity and diabetes are well known. On the other hand, data regarding frequency and timing of meals and how these factors relate to corporal weight are not totally understood.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2; Overweight and Obesity; Meal Time
• Intervention / Treatment: Other: Comparing 3 versus 5 meals in type 2 diabetes patients

Detailed Description

In general, hypocaloric plans for patients with type 2 diabetes mellitus are consumed in five or six small meals per day. Eating more often is presumed to reduce hunger and thus energy consumption. However, the effects of meal frequency on human health and longevity are unclear.

Therefore, this study will be carried out in which the differences in the impact of nutritional therapy between a hypocaloric conventional 5 times meal versus a 3-meal low-calorie plan will be demonstrated.

The procedures will be as follows:

50 patients with DM2 from the Institute's Diabetes Clinic who are overweight or obese and between 40 and 70 years of age and who are found to have oral hypoglycemic agents, HbA1c less than 9% and less than 10 years old will be recruited of evolution.

Clinical evaluation:

A complete medical history and physical examination will be performed in order to confirm the presence of the inclusion criteria and rule out the presence of exclusion criteria. An anthropometric and body composition assessment (waist and hip circumference, height, weight and percentage of fat) as well as blood pressure measurement will be made. A history of coronary heart disease, menopausal status and use of hormone therapy, smoking, alcohol consumption and physical activity (through a questionnaire of physical activity validated in the Mexican population) will be conducted.

Nutritional assessment:

Patients will be divided into 2 groups without any distinction.

The first group of 25 patients will undergo a caloric restriction with a caloric restriction of 15% of their usual daily intake with a 40% macronutrient distribution in Carbohydrates, 20% Protein and 40% Lipids in three times of (TC5) over a period of 12 weeks in which the following variables will be measured: (Weight, Glucose Variability: Monitor, HbA1c, blood glucose, Lipid Profile, Oxidative stress, FGF-21, Blood Pressure and Hunger-Satiety Levels.)

At the first visit, the clinical evaluation will be elaborated, which consists of a complete physical examination in which vital signs will be measured, neck and head examination, examination of the thorax and abdomen, exploration of upper and lower extremities. As well as a complete nutritional assessment that includes; Assessment of body composition using bioimpedance with body composition analyzer jawon iOi 353, Reminder of food consumption of 72hrs to collect information on the diet of each patient. Based on the information collected will proceed to prescribe the individualized TC5 plan and will be given a 24/7 reminder format to be filled by the patient for a week, in addition to giving the indication to perform home glucose measurement once a day In random scheme.

To evaluate attachment to the nutritional plan, the patient will be cited 15 days later to perform daily consumption assessment using the 24/7 reminder format filled out by the patient and a 72hrs reminder performed through an interview. Likewise, levels of Hunger-Satiety will be measured with the tables of the institute Joslin validated for Mexican population.

If the patient adheres to the diet, blood samples will be taken for the measurement of the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) and after that place the Medtronic model Ipro2 continuous glucose monitor with In order to monitor the patient's blood glucose for 7 days.

At the end of the 7 days, the patient will be asked to remove the sensor and re-evaluate dietary attachment.

The TC5 plan will be continued for 6 weeks, and at the end of this period the patient will be recalled to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) Blood pressure and levels of Hunger-Satiety.

The TC5 regimen will be continued for a further 6 weeks. At the end of the period the patient will be asked to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21), Weight, Blood Pressure and Hunger-Satiety levels.

The second group of 25 patients will undergo a caloric restriction with a caloric restriction of 15% of their usual daily intake, with a 40% macronutrient distribution in Carbohydrates, 20% Protein and 40% Lipids in three times of (TC3) over a period of 12 weeks in which the following variables (Weight, Glucose Variability: Monitor, HbA1c, blood glucose, Lipid Profile, Oxidative, FGF-21, Blood Pressure and Hunger-Satiety levels are measured.) At the first visit, the clinical evaluation will be elaborated, which consists of a complete physical examination in which vital signs will be measured, neck and head examination, examination of the thorax and abdomen, exploration of upper and lower extremities. As well as a complete nutritional evaluation that includes, assessment of body composition using bioimpedance with jawon iOi 353 body composition analyzer, food consumption reminder of 72hrs to collect information on each patient's diet. Based on the information collected will proceed to prescribe the individualized TC3 plan and will be given a 24/7 reminder format to be filled by the patient for a week, in addition to giving the indication to perform home glucose measurement once a day in random scheme.

To evaluate attachment to the nutritional plan, the patient will be cited 15 days later to perform daily consumption assessment using the 24/7 reminder format filled out by the patient and a 72hrs reminder performed through an interview. Likewise, levels of Hunger-Satiety will be measured with the tables of the institute Joslin validated for Mexican population.

If the patient adheres to the diet, blood samples will be taken for the measurement of the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) and after that place the Medtronic model Ipro2 continuous glucose monitor with in order to monitor the patient's blood glucose for 7 days.

At the end of the 7 days, the patient will be asked to remove the sensor and re-evaluate dietary attachment.

The TC3 plan will be continued for 6 weeks, and at the end of this period the patient will be recalled to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21) Blood pressure and levels of Hunger-Satiety. The TC3 regimen will be continued for a further 6 weeks. At the end of the period the patient will be asked to re-perform blood samples to measure the variables (HbA1C, Glucose, Lipid Profile, Insulin, FGF-21), Weight, Blood Pressure and Hunger-Satiety levels.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 14080
      • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ''

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Oral hypoglycemic agents
• HbA1c <9%
• Less than 10 years of evolution
• Diabetes Mellitus type 2
• Overweight or obese
• Age 40-70 years
• BMI ≥25 to < 40 kg/m

Exclusion Criteria:

• Obesity 3rd grade
• DM 1
• Hospitalization in the last 3 months
• >10 years of evolution
• HbA1c >9%
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 meals; Patients with type 2 diabetes will be submitted to a 3 meal regimen for 3 months. We will compare their basal complete blood chemistry, somatometric measurements versus the same variables after 3 months.	Other: Comparing 3 versus 5 meals in type 2 diabetes patients; We will compare a 3 meals regimen versus a 5 meal regimen in patients with type 2 diabetes and overweight or obesity, to analyze which of the regimens have better outcomes in glycemic variability
Experimental: 5 meals; Patients with type 2 diabetes will be submitted to a 5 meal regimen for 3 months. We will compare their basal complete blood chemistry, somatometric measurements versus the same variables after 3 months.	Other: Comparing 3 versus 5 meals in type 2 diabetes patients; We will compare a 3 meals regimen versus a 5 meal regimen in patients with type 2 diabetes and overweight or obesity, to analyze which of the regimens have better outcomes in glycemic variability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of 3 stroke diet in glycemic variability compared to a 5 stroke diet	Patients from both groups (3 stroke and 5 stroke diet) will be monitored for 7 days using intensive capillar blood glucose measurements 4 times per day (Fasting, 2 hours post breakfast, 2 hours post meal and 2 hours post dinner). The basal intensive blood glucose meaasurement monitoring will start at week 1 (first visit), and will end at day 7 and final intensive blood glucose meaasurement monitoring will start at week 11 and will end 7 days after (final visit) comparing glycemic variability between them. Mean difference of glycaemic variability (MAGE) calculated in mmol/L.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of 3 stroke diet in glycosylated hemoglobin levels compared to a 5 stroke diet	Mean difference of glycosylated hemoglobin represented in %	12 weeks
Impact of 3 stroke diet in fasting glucose levels compared to a 5 stroke diet	Mean difference of fasting glucose represented in mg/dL	12 weeks
Impact of 3 stroke diet in triglycerides levels compared to a 5 stroke diet	Mean difference of triglycerides represented in mg/dL	12 weeks
Impact of 3 stroke diet in cholesterol levels compared to a 5 stroke diet	Mean difference of cholesterol levels represented in mg/dL	12 weeks
Impact of 3 stroke diet in fibroblast growth factor 21 levels compared to a 5 stroke diet	Mean difference of fibroblast growth factor 21 levels represented in pg/ml.	12 weeks
Impact of 3 stroke diet in systolic and diastolic blood pressure compared to a 5 stroke diet	Mean difference of systolic and diastolic blood pressure represented in mmHg	12 weeks
Impact of 3 stroke diet in satiety compared to a 5 stroke diet	The mean difference in satiety will be estimated using the Queensland University's hunger-satiety questionnaire, which consists of a score ranging from 1 to 10, where 1 represents the highest level of hunger and 10 represents the highest level of satiety.	12 weeks
Impact of 3 stroke diet in weight loss compared to a 5 stroke diet	Mean difference of weight represented in kilograms	12 weeks

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborators: L.N. Adrián Romero Villaseñor; L.N. Aurora Ramos Flores; L.N. Mariana Galindo Guzmán; Dr. Daniel Cuevas Ramos; Dr. Adrian Soto Mota; Dr. Francisco J. Gómez Pérez; Dr. Alfonso Gulias Herrero; Lucía Palacios Baez; Gerardo Saavedra Jiménez; Hector Donaldo Espinosa Salazar; Issa Lill Santiago Falfán; Cristina Aurora Tlapanco Beltrán; Horacio Correa Carranza; Alejandra Dominguez Sanchez
• Investigators: Principal Investigator: Miguel Angel Gómez Sámano, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2018
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): March 11, 2025

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: October 12, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No