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.
Patients over 18 years of age.
Diagnosis of diabetes mellitus type 2.
HbA1c >7% to <11%.
BMI >27 kg/mt2 <35 kg/mt2
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.
Parallel
Glucerna
Dietary supplementA 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 interventionDietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
Time in range
Time in range 70 - 180 mg/dl
HbA1c
HbA1c
Weight
Weight in kilograms
body composition
fat mass, musculoskeletal mass, visceral fat mass
Map coordinates are unavailable for these locations. Locations are shown below instead.
ColombiaClick on the lead sponsor to view all of their trials.
Hospital Universitario San Ignacio
Lead sponsor
Abbott Nutrition
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
