Glycemic Variability Comparing Two vs Five Meals in Type 2 Diabetes

NCT04127994 | Completed

• 1 other identifier: 2100
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type 2; Overweight and Obesity; Meal Time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Impact of 3 stroke diet in glycosylated hemoglobin levels compared to a 5 stroke diet

  12 weeks

• Impact of 3 stroke diet in fasting glucose levels compared to a 5 stroke diet

  12 weeks

• Impact of 3 stroke diet in triglycerides levels compared to a 5 stroke diet

  12 weeks

• Impact of 3 stroke diet in cholesterol levels compared to a 5 stroke diet

  12 weeks

• Impact of 3 stroke diet in fibroblast growth factor 21 levels compared to a 5 stroke diet

  12 weeks

Study Arms (2)

3 meals

EXPERIMENTAL

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

5 meals

EXPERIMENTAL

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

Interventions

Comparing 3 versus 5 meals in type 2 diabetes patients OTHER

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

3 meals; 5 meals

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ''

Mexico City, Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Miguel Angel Gómez Sámano, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: October 16, 2019
• Study Start: August 17, 2018
• Primary Completion: December 11, 2023
• Study Completion: March 11, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

ME (1)