Influence of the Use of Specific Nutritional Formulas on Time in Range in Patients With Type 2 Diabetes
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
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Diana C Henao-Carrillo, Endocrinologyst
- Telefonnummer: 2817 +57 601 5946161
- E-post: dchenao@husi.org.co
Studer Kontakt Backup
- Navn: Ana M Gómez - Medina, Endocrinologyst
- Telefonnummer: 2817 +57 601 5946161
- E-post: agomez@husi.org.co
Studiesteder
-
-
Cundinamarca
-
Bogotá, Cundinamarca, Colombia, 111021
- Hospital Universitario San Ignacio
-
Ta kontakt med:
- Diana C Henao-Carrillo, Endocrinologyst
- Telefonnummer: 2817 +57 601 5946161
- E-post: dchenao@husi.org.co
-
Ta kontakt med:
- Ana M Gómez Medina, Endocrinologyst
- Telefonnummer: 2817 +57 601 5946161
- E-post: agomez@husi.org.co
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
|
|
Placebo komparator: Placebo
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time in range
Tidsramme: 3 months
|
Time in range 70 - 180 mg/dl
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
HbA1c
Tidsramme: 3 months
|
HbA1c
|
3 months
|
|
Weight
Tidsramme: 3 months
|
Weight in kilograms
|
3 months
|
|
body composition
Tidsramme: 3 months
|
fat mass, musculoskeletal mass, visceral fat mass
|
3 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ana M Gómez-Medina, Endocrinologyst, Hospital Universitario San Ignacio
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Ernæringsforstyrrelser
- Metabolske sykdommer
- Overernæring
- Kroppsvekt
- Glukosemetabolismeforstyrrelser
- Sukkersyke
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Overvektig
- Overvekt
- Diabetes mellitus, type 2
- Terapeutikk
- Kosthold, mat og ernæring
- Fysiologiske fenomener
- Ernæringsfysiologiske fenomener
- Kostholdsterapi
- Ernæringsterapi
- Kosthold
- Energiinntak
- Kaloribegrensning
- Glucerna
Andre studie-ID-numre
- FM-CIE-0840-24
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