Role of Glucagon In Glucose Control in Cystic Fibrosis Related Diabetes
24 giugno 2020 aggiornato da: Yale University
Role of Glucagon in Glucose Control in Cystic Fibrosis Related Diabetes
This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance.
Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related diabetes as well as control subjects will undergo an oral glucose tolerance test, mixed meal tolerance test, and one step hypoglycemic clamp.
Cystic fibrosis patients will then return 12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance. This will be a descriptive, cross-sectional and longitudinal cohort study in a sample of children and young adults with CF and a continuum of glucose tolerance compared to healthy age-matched controls.
Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related diabetes as well as control subjects will be admitted to the research unit on three separate occasions to undergo an oral glucose tolerance test, mixed meal tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
7
Fase
- Prima fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06511
- Yale New Haven Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 12 anni a 45 anni (Bambino, Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Diagnosis of CF by clinical or genetic determination
- Normal glucose tolerance or CFRD
- Subjects routinely taking systemic or inhaled glucocorticoids on stable regimen are eligible
Exclusion Criteria:
- Subjects with active pulmonary infection requiring supplemental doses of corticosteroids
- Use of any oral diabetes medications
- Subjects who are pregnant/lactating
- Subjects with poor compliance with pancreatic enzyme replacement therapy
Control Subjects:
Approximately 10 control subjects who are matched for age, gender, are expected to be enrolled in the study. Non-CF subjects must be >12 years old, in good health and not taking any medications or have any medical problems the doctor feels would prevent the subject from completing the study and have BMI between 15-85% for age and gender. Control subjects whose fasting blood glucose is found to be >110 mg/dL will not be continued in the study.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: CF with Normal Glucose Tolerance
Individuals with CF without cystic fibrosis related diabetes
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Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm.
Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes.
Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml.
Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
All subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose.
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Sperimentale: Cystic Fibrosis Related Diabetes
Individuals with cystic fibrosis and cystic fibrosis related diabetes
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Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm.
Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes.
Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml.
Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
All subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose.
|
|
Comparatore attivo: Control
Age matched control subjects
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Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm.
Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes.
Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml.
Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
All subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Glucagon levels
Lasso di tempo: baseline
|
Glucagon levels in response to to a mixed meal stimulus
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baseline
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
C-peptide levels
Lasso di tempo: baseline
|
C-peptide levels during oral glucose tolerance test and mixed meal tolerance test
|
baseline
|
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C-peptide levels
Lasso di tempo: 12 months
|
C-peptide levels during oral glucose tolerance test and mixed meal tolerance test
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12 months
|
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Epinephrine levels
Lasso di tempo: baseline
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Epinephrine and norepinephrine levels during hypoglycemic clamp
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baseline
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Epinephrine levels
Lasso di tempo: 12 months
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Epinephrine and norepinephrine levels during hypoglycemic clamp
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12 months
|
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Norepinephrine levels
Lasso di tempo: baseline
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norepinephrine levels during hypoglycemic clamp
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baseline
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Norepinephrine levels
Lasso di tempo: 12 months
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norepinephrine levels during hypoglycemic clamp
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12 months
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Hypoglycemia unawareness scores
Lasso di tempo: Baseline
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Hypoglycemia unawareness scores in subjects during hypoglycemic clamps as measured by the Clarke Hypoglycemia Awareness survey
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Baseline
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Hypoglycemia unawareness scores
Lasso di tempo: 12 months
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Hypoglycemia unawareness scores in subjects during hypoglycemic clamps as measured by the Clarke Hypoglycemia Awareness survey
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12 months
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GLP-1 and GIP levels
Lasso di tempo: Baseline
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GLP-1 and GIP levels in response to mixed meal stimulus
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Baseline
|
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GLP-1 and GIP levels
Lasso di tempo: 12 months
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GLP-1 and GIP levels in response to mixed meal stimulus
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12 months
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Glucagon levels
Lasso di tempo: 12 months
|
Glucagon levels in response to to a mixed meal stimulus and difference from baseline
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12 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Bracha Goldsweig, MD, Yale University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2015
Completamento primario (Effettivo)
22 giugno 2017
Completamento dello studio (Effettivo)
22 giugno 2017
Date di iscrizione allo studio
Primo inviato
22 gennaio 2015
Primo inviato che soddisfa i criteri di controllo qualità
19 marzo 2015
Primo Inserito (Stima)
25 marzo 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 giugno 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 giugno 2020
Ultimo verificato
1 giugno 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Processi patologici
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Malattie delle vie respiratorie
- Malattie polmonari
- Malattie del sistema endocrino
- Infante, neonato, malattie
- Malattie genetiche, congenite
- Malattie pancreatiche
- Fibrosi
- Diabete mellito
- Fibrosi cistica
- Effetti fisiologici delle droghe
- Agenti ipoglicemizzanti
Altri numeri di identificazione dello studio
- 1409014580
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .