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

Sponsor
Hospital Universitario San Ignacio
Study ID
NCT07666581
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jun 24, 2026
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
198 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Placebo Comparator: Placebo
    Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.

Primary Outcome Measure

Time in range [ Time Frame: 3 months ]

Central Contacts

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