Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04127994 |
| Other study ID # |
2100 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 17, 2018 |
| Est. completion date |
October 11, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Contact |
Miguel Angel Gómez Sámano, MD |
| Phone |
55 54870900 |
| Email |
miguelangelgomezsamano[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 6 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 (TC6) 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 TC6 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 TC6 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 TC6 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.
