An interventional study of Glucerna and Caloric restriction in Type 2 Diabetes, Obesity & Overweight and Time in Range, sponsored by Hospital Universitario San Ignacio. Not yet recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Hospital Universitario San Ignacio · Not applicable, Interventional, and Treatment
Who can participate?
Individuals may be eligible to join this study if they meet the following criteria:
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 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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 198 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Hospital Universitario San Ignacio is the lead sponsor of 25 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 Supplement: Glucerna · Other: Caloric restriction
Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
Other: Caloric restriction
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.
Dietary 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
Time frame: 3 months
HbA1c
HbA1c
Time frame: 3 months
Weight
Weight in kilograms
Time frame: 3 months
body composition
fat mass, musculoskeletal mass, visceral fat mass
Time frame: 3 months
Plan to share: No — The datasets generated during and/or analyzed during the current study are not publicly available due contains clinical data of patients being monitored at the Hospital Universitario San Ignacio but are available from the corresponding author on reasonable request.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glucerna
Hospital Universitario San Ignacio