Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07666581

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes, Obesity & Overweight, Time in Range

Full registry criteria

Inclusion criteria: * 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). Exclusion criteria: * 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.

Treatments and study arms

Glucerna

Dietary Supplement

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.

Caloric restriction

Other

Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.

Primary outcomes

Time in range3 months

Time in range 70 - 180 mg/dl

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hospital Universitario San Ignacio🇨🇴 Bogotá, Cundinamarca, Colombia

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Ana M Gómez Medina, EndocrinologystContact

Email · Call +57 601 5946161

Diana C Henao-Carrillo, EndocrinologystContact

Email · Call +57 601 5946161