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Набор скоро начнётся NCT07714759

A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention

Без фазы С лечением Obesity & Overweight Obese Adolescents Metabolic Abnormalities

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Use of an unblinded CGM device.
Кому может быть актуально
Состояния в реестре: Obesity & Overweight, Obese Adolescents, Metabolic Abnormalities. Базовые параметры: 13 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The objective of this project is to determine the feasibility of introducing CGMs to adolescent patients with obesity and pre-diabetes (Hemoglobin A1C: HbA1C between 5.7-6.5%) to determine whether their eating habits and subsequent glucose profiles are modified by the timely awareness of glucose excursions above the diabetes threshold of 200 mg/dl.

Подробное описание

Building on prior UF protocols and national ORBIT-model guidance for early-phase behavioral-treatment development, this study represents a Phase I/IIa feasibility and signal-of-efficacy trial. The study is a comparison of food choice and decision making between a NO CGM group and a Open-label CGM group. Several bio markers are used to determine the consequences of nutritional choices. This information is used in nutritional counselling sessions.

Вмешательства

  • Устройство Use of an unblinded CGM device
    Open use of CGM device where patients can see their blood glucose values.

Первичные конечные точки

  • Total caloric intake [Срок оценки: Baseline; 3 Months]
  • Total grams of carbohydrates from sugar [Срок оценки: Baseline; 3 Months]
Вторичные конечные точки (5)
  • 5-point Likert scale Questionnaire of child food understanding [Срок оценки: Baseline; 3 Months]
  • Metabolic outcome - Difference in Hba1c [Срок оценки: Baseline; 3 Months]
  • Metabolic outcome - Difference in BMI Z score [Срок оценки: Baseline; 3 Months]
  • Metabolic outcome - Difference in complete metabolic panel [Срок оценки: Baseline; 3 Months]
  • Differences in Fitness assessment scores [Срок оценки: Baseline; 3 Months]

Критерии участия

Критерии включения

  • Children aged 13-17 years.
  • BMI ≥ 95 percentile
  • BMI >85th and BMI < 95th percentile for age and sex (CDC growth charts) if the risk factors below are present: Family history of type 2 diabetes in first or second degree relative:
  • Race/ethnicity Native American, African American, Latino, Asian American, Pacific Islander
  • Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestational-age birth weight)
  • Maternal history of diabetes or gestational diabetes mellitus (GDM) during the child's gestation
  • Receiving care through HCN for pediatric or family medicine clinics.
  • No structured nutritional intervention in the past 3 months.
  • Parent/guardian able to provide informed consent and child able to assent.
  • Family has access to a smartphone or is willing to use a study-provided device for CGM viewing and communication.
  • Willingness to comply with study visits, CGM wear, and laboratory testing.

Критерии исключения

An individual who meets any of the following criteria will be excluded from participation:

  • Diabetes by history or HbA1c ≥ 6.5 % in the medical record or at screening.
  • Unable or unwilling to provide consent or participate fully in study activities.
  • Conditions predisposing to diabetes or altering normal pubertal development.
  • Current or planned use of medications affecting glucose dynamics, including:

o Insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, or other glucose-lowering or weight-loss medications within 6 weeks prior to enrollment or planned during the study period.

  • Known syndromic or monogenic obesity.
  • Blood disorders that impact HbA1c interpretation (e.g., anemia, and hemoglobin variants).
  • Major systemic organ disease (renal, hepatic, or cardiac).
  • History or planned bariatric surgery.
  • Current pregnancy or plans for pregnancy during the study.
  • Use or planned use of GnRH agonists, estrogen, or testosterone.
  • Non-English- or non-Spanish-speaking individuals, as validated questionnaires are available only in these languages.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • University of Florida — Gainesville

Идентификаторы

NCT: NCT07714759 · IRB202600180 · AGR00036900

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗