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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Diana C Henao-Carrillo, Endocrinologyst
- 전화번호: 2817 +57 601 5946161
- 이메일: dchenao@husi.org.co
연구 연락처 백업
- 이름: Ana M Gómez - Medina, Endocrinologyst
- 전화번호: 2817 +57 601 5946161
- 이메일: agomez@husi.org.co
연구 장소
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Cundinamarca
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Bogotá, Cundinamarca, 콜롬비아, 111021
- Hospital Universitario San Ignacio
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연락하다:
- Diana C Henao-Carrillo, Endocrinologyst
- 전화번호: 2817 +57 601 5946161
- 이메일: dchenao@husi.org.co
-
연락하다:
- Ana M Gómez Medina, Endocrinologyst
- 전화번호: 2817 +57 601 5946161
- 이메일: agomez@husi.org.co
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
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위약 비교기: Placebo
Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
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Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time in range
기간: 3 months
|
Time in range 70 - 180 mg/dl
|
3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
HbA1c
기간: 3 months
|
HbA1c
|
3 months
|
|
Weight
기간: 3 months
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Weight in kilograms
|
3 months
|
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body composition
기간: 3 months
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fat mass, musculoskeletal mass, visceral fat mass
|
3 months
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Ana M Gómez-Medina, Endocrinologyst, Hospital Universitario San Ignacio
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FM-CIE-0840-24
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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