Comparing the effects of three versus six meals on diabetes management
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 Six Meals in Patients With Type 2 Diabetes With Overweight or Obesity
This study tests whether eating three meals a day or six meals a day helps people with type 2 diabetes manage their blood sugar and weight better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Academic / other |
| Locations | 1 site (Ciudad de mexico) |
| Trial ID | NCT04127994 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of meal frequency on glycemic control in overweight or obese patients with type 2 diabetes. Participants will be divided into two groups, one consuming three meals and the other six meals per day, both following a low-calorie diet. The study aims to assess how these different meal frequencies affect blood glucose levels, weight management, and overall health outcomes. Clinical evaluations and nutritional assessments will be conducted to ensure participant eligibility and monitor health changes throughout the study.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese adults aged 40-70 with type 2 diabetes, controlled with oral hypoglycemic agents and an HbA1c level below 9%.
Not a fit: Patients with type 1 diabetes, severe obesity, or those with a history of hospitalization in the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal meal frequency for better diabetes management and weight loss.
How similar studies have performed: While meal frequency has been studied in various contexts, this specific comparison of three versus six meals in type 2 diabetes patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ciudad de mexico
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ'' — Ciudad de mexico, Mexico (Recruiting)
Study contacts
- Principal investigator: Miguel Angel Gómez Sámano, MD — Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study coordinator: Miguel Angel Gómez Sámano, MD
- Email: miguelangelgomezsamano@gmail.com
- Phone: 55 54870900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.