Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects
8 avril 2022 mis à jour par: Yale University
To investigate whether the daily glucose profiles as assessed by continuous glucose monitoring for 1 week of normal weight and obese individuals relate to hunger levels and food intake.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
To evaluate the effect of blood glucose levels on eating behavior in a population of patients with diabetes in a free-living environment; the investigators plan to study lean healthy control subjects (BMI <25 kg/m2) and obese non-diabetic subjects (BMI > 30 kg/m2).
The participants who qualify will be invited to use the CGMS (DEXCOM G4 Platinum) for up to 7 days. On the visit for placement of the CGMS: 1) the participants will be explained by one of the study physicians how to use a glucometer (FreeStyle or Accu-Check), 2) they will have the CGMS inserted under the skin, and 3) they will be instructed how to fill up the food log (informational brochures are available at the end of the protocol. On the second visit (up to 7 days after the initial visit) the CGMS will be removed from the skin and the glucose meter and food log will be returned to the investigators.
When this study was initially designed, it incorporated 2 additional arms in the study: T1DM and obese T2DM patients. These patients were never recruited for the study.
Type d'étude
Interventionnel
Inscription (Réel)
31
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Connecticut
-
New Haven, Connecticut, États-Unis, 06520
- Yale University School Of Medicine
-
New Haven, Connecticut, États-Unis, 06519-1362
- Yale New Haven Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- A1c < 10.5 %
Exclusion Criteria:
- BMI <18 (no upper limit),
- Creatinine > 1.5 mg/dL,
- Hgb < 10 mg/dL,
- ALT > 2.5 X ULN,
- untreated thyroid disease,
- uncontrolled hypertension,
- known neurological disorders,
- untreated psychiatric disorders,
- use of antidepressants and psychiatric medications,
- use of weight loss medications in the 6 months prior to the study,
- malignancy,
- smoking,
- current or recent steroid use in last 3 months,
- history of current illicit drug use;
- for women: pregnancy, or breastfeeding.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Lean Healthy Control
(BMI <25 kg/m2)
|
The CGMS consists of 3 parts: sensor, transmitter and monitor.
The small sensor measures the glucose levels from the interstitial tissue.
The transmitter is attached on top of the sensor and connects wirelessly to the monitor.
The sensor is sterile and comes in an unopened package.
It has a plastic wire-like tip that is placed under the skin and continuously measures the glucose levels.
One of the study physicians will insert the CGMS wire-like tip under the volunteer's skin with the use of the DEXCOM sensor insertion kit.
The transmitter is snapped to the sensor pod and the sensor/transmitter unit will be attached to the skin with an adhesive patch.
The monitor is the size of a small hand-held device with a digital screen that displays a graph showing the glucose levels from the previous 4-24 hours.
Autres noms:
The Food Record will ask about amount and type of food consumed throughout the day.
The participants will also register how hungry they are before the meal and how full they feel after they ate, and type and duration of physical activity
|
|
Comparateur actif: Obese non-diabetic subject
BMI > 30 kg/m2
|
The CGMS consists of 3 parts: sensor, transmitter and monitor.
The small sensor measures the glucose levels from the interstitial tissue.
The transmitter is attached on top of the sensor and connects wirelessly to the monitor.
The sensor is sterile and comes in an unopened package.
It has a plastic wire-like tip that is placed under the skin and continuously measures the glucose levels.
One of the study physicians will insert the CGMS wire-like tip under the volunteer's skin with the use of the DEXCOM sensor insertion kit.
The transmitter is snapped to the sensor pod and the sensor/transmitter unit will be attached to the skin with an adhesive patch.
The monitor is the size of a small hand-held device with a digital screen that displays a graph showing the glucose levels from the previous 4-24 hours.
Autres noms:
The Food Record will ask about amount and type of food consumed throughout the day.
The participants will also register how hungry they are before the meal and how full they feel after they ate, and type and duration of physical activity
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of Changing Glucose Level
Délai: 3-5 days
|
The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the rate of changing glucose level (mg/dl/min).
|
3-5 days
|
|
Glucose Peak
Délai: 3-5 days
|
The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the glucose peak (mg/dl).
|
3-5 days
|
|
Glucose Nadir
Délai: 3-5 days
|
The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the glucose nadir (mg/dl).
|
3-5 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in Glucose Peak and Nadir
Délai: 3-5 days
|
The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the difference in glucose peak and nadir (mg/dl).
|
3-5 days
|
|
Average Daily Hunger Rating
Délai: 3-5 days
|
Average daily hunger was measured using a self-report scale.
Hunger is measured on a scale from 1-10. 10 is the most hungry, 1 is the least hungry.
|
3-5 days
|
|
Nutirion Intake: Energy
Délai: 3-5 days
|
Data were collected through food journals.
Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R).
Presented is the average daily energy intake (kcal/day).
|
3-5 days
|
|
Nutirion Intake: Carbohydrate
Délai: 3-5 days
|
Data were collected through food journals.
Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R).
Presented is the average daily carbohydrate intake (g/day).
|
3-5 days
|
|
Nutirion Intake: Fat
Délai: 3-5 days
|
Data were collected through food journals.
Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R).
Presented is the average daily fat intake (g/day).
|
3-5 days
|
|
Nutirion Intake: Protein
Délai: 3-5 days
|
Data were collected through food journals.
Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R).
Presented is the average daily protein intake (g/day).
|
3-5 days
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Renata Belfort De Aguiar, MD, PhD, Yale School of Medicine
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 février 2016
Achèvement primaire (Réel)
14 décembre 2017
Achèvement de l'étude (Réel)
14 décembre 2017
Dates d'inscription aux études
Première soumission
1 février 2016
Première soumission répondant aux critères de contrôle qualité
2 février 2016
Première publication (Estimation)
3 février 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 mai 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 avril 2022
Dernière vérification
1 avril 2022
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 1503015469
- 1K23DK098286-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .