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AAAT8914

Lifestyle patterns and glycemic control
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05224986
Recrutement ouvert
Dernière modification : 2024/08/14
Type de recherche

Interventionnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Pre-diabetic kg/m2 (hemoglobin A1c 5.7-6.9%)
* 25 years or older
* BMI between 25-39.9 kg/m2
* Sleep duration ≥6 hours a night assessed with wrist actigraphy (for 14 nights)
* Variable bedtime, SD≥45 minutes.

Exclusion Criteria:

* Chronic Kidney Disease (GFR\<60)
* Uncontrolled hypertension (≥160/100 mmHg)
* Obstructive Sleep Apnea
* Psychiatric or neurological disorder
* Prevalent cardiovascular disease
* Dyslipidemia (triglycerides≥200 mg/dL)
* Medications that affect insulin sensitivity, glucose concentrations, and body weight
* Non-day or rotating shift workers
* Travel across time zones
* Active participation in weight loss program or within past 3 months
* Current or past alcohol/drug abuse

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Variable Schedule Participants randomized to Variable Schedule (VS) will be asked to maintain their usual habits for 12 weeks. Donnée non disponible
  • Inconnu
  • Fixed Schedule Participants randomized to Fixed Schedule (FS) will be asked to stabilize their lifestyle behaviors for 12 weeks. Donnée non disponible
  • Inconnu
  • Variable Schedule
    État du recrutement
    unknown
    Fixed Schedule
    État du recrutement
    unknown
    Données à jour depuis : 14 août 2024

    Description de l'étude

    Résumé de l'étude

    The goal of the proposed study is to evaluate the feasibility and initial efficacy of stabilizing lifestyle behaviors to improve glucose control and body composition in patients with pre-diabetes.

    The investigator proposes that following stable lifestyle behaviors will improve patients' glucose control, body composition, and liver fat. The results from this study has the potential to impact clinical practice and patient care.

    Source : Importé depuis le centre

    Variability in lifestyle behaviors has been associated with adverse health, specifically poor glucose control. The project proposes to test whether reducing this variability improves glycemia in patients with pre-diabetes. If successful, this simple positive lifestyle message to keep stable behaviors has the potential to improve the health of millions of adults worldwide.

    This project will enroll participants with pre-diabetes who have erratic lifestyle behaviors and randomize them to either maintain their usual habits (control group) or stabilize their behaviors (stability group). Both groups will be followed for 12 weeks. Before the start of the 12-week period, all participants will track their sleep for 2 weeks and will wear a glucose monitor to measure their glucose levels. At the start and end of the 12-week period, they will come to the research lab to undergo a glucose tolerance test. This test will measure how their body reacts to a glucose load. They will also undergo magnetic resonance imaging and spectroscopy scanning. This scan will provide information on body composition and liver fat content.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 14 août 2024
    Données à jour depuis : 16 août
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT05224986