Influence of the Use of Specific Nutritional Formulas on Time in Range in Patients With Type 2 Diabetes

Официальное название

Influence of the Use of Specific Nutritional Formulas for Diabetes on Time in Range in Patients With Type 2 Diabetes Mellitus With Obesity by Freestyle Continuous Glucose Monitoring

Обзор

Who can participate? Individuals may be eligible to join this study if they meet the following criteria: * Are 18 years or older. * Have Type 2 diabetes with an A1c level higher than 7%. * Have a Body Mass Index (BMI) between 27 and 35 (considered overweight or Class 1 obesity). * Have used a continuous glucose monitor (CGM) successfully in the past. How the study works: If eligible individuals decide to join and sign the consent form, a computer will randomly assign them into one of two groups: The Formula Group: Participants will replace their usual breakfast and one snack with a specific diabetes nutritional drink (Glucerna®). The Standard Diet Group: Participants will follow a standard low-calorie meal plan without using the nutritional drink. Both groups will aim for a specific daily calorie goal (1,200-1,500 for women; 1,500-1,800 for men) and will receive expert nutritional counseling. Monitoring and Follow-up Over the course of 3 months, close contact will be maintained to support participants: Every 2 weeks: A nutrition expert will call participants to check on their diet and help with their glucose monitor. Every month: Participants will meet with the study team in person to review glucose monitor data. Tests: At the start and end of the study, weight, body composition, blood sugar (A1c), and cholesterol levels will be measured to see how the plans worked.

Подробное описание

A randomized controlled clinical trial will be conducted with two parallel groups, which will include patients over 18 years of age with type 2 DM, HbA1c \> 7%, and grade 1 obesity (BMI \>27 kg/m2 and \<35 kg/m2), who have previously used continuous glucose monitoring (CGM) with adherence greater than 70%, and who are able to follow the study protocol.

After signing the informed consent, REDcap® will be used to computer-generate the random sequence for group assignment; the intervention group will use a specific nutritional formula for diabetes (FNED) (Glucerna®) (Appendix 1) as a replacement for breakfast and snack to achieve targets of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men, and the control group will continue to be prescribed a low-calorie diet of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men without the use of FNED for a period of 3 months. Both groups will receive nutritional counseling according to the diabetes support and self-care education plan.

CGM, body composition, and baseline paraclinical variables will be collected, and every 14 days, adherence to dietary treatment will be verified by telephone using a 24-hour multi-step reminder with advice from a dietary team, and correct use of the device will be verified. CGM records are reviewed in person monthly using the LibreView" platform. CGM data, body composition and HbA1c, total cholesterol, HDL, LDL, baseline triglycerides will be analyzed at 3 months of follow-up.

Вмешательства

• Пищевая добавка Glucerna
  A calorie-restricted diet plan is prescribed (see Table 1). In this group, Glucerna will be prescribed for breakfast and snacks as part of the total calories calculated for each patient's meal plan. Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
• Другое Caloric restriction
  Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.

Первичные конечные точки

• Time in range [Срок оценки: 3 months]

Вторичные конечные точки (3)

• HbA1c [Срок оценки: 3 months]
• Weight [Срок оценки: 3 months]
• body composition [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Patients over 18 years of age.
• Diagnosis of diabetes mellitus type 2.
• HbA1c >7% to <11%.
• BMI >27 kg/mt2 <35 kg/mt2
• Current use of continuous glucose monitoring with adherence greater than 70%.
• Access to technology to download data from CGM in a timely manner.
• Ability to follow the study protocol and provide informed consent (Appendix 3).

Критерии исключения

• Change in antidiabetic medication in the last 3 months.
• Pregnancy or lactation or planning to become pregnant during the study period.
• Acute decompensation of diabetes in the past 3 months.
• Participation in another clinical trial.
• Use of glucocorticoids or insulin in the past 3 months or planned use in the coming months.
• Initiation of treatment with oral or injectable GLP-1 analogues 3 months prior to enrollment.
• History of bariatric surgery or gastrointestinal pathology associated with malabsorption syndromes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Колумбия · 1 центр

• Hospital Universitario San Ignacio — Bogotá

Идентификаторы

NCT: NCT07666581 · FM-CIE-0840-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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