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- Klinische proef NCT02398383
Role of Glucagon In Glucose Control in Cystic Fibrosis Related Diabetes
Role of Glucagon in Glucose Control in Cystic Fibrosis Related Diabetes
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Vroege fase 1
Contacten en locaties
Studie Locaties
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06511
- Yale New Haven Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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.
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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Glucagon levels
Tijdsspanne: baseline
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Glucagon levels in response to to a mixed meal stimulus
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baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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C-peptide levels
Tijdsspanne: baseline
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C-peptide levels during oral glucose tolerance test and mixed meal tolerance test
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baseline
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C-peptide levels
Tijdsspanne: 12 months
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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
Tijdsspanne: baseline
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Epinephrine and norepinephrine levels during hypoglycemic clamp
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baseline
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Epinephrine levels
Tijdsspanne: 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
Tijdsspanne: baseline
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norepinephrine levels during hypoglycemic clamp
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baseline
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Norepinephrine levels
Tijdsspanne: 12 months
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norepinephrine levels during hypoglycemic clamp
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12 months
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Hypoglycemia unawareness scores
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 12 months
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Glucagon levels in response to to a mixed meal stimulus and difference from baseline
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12 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Bracha Goldsweig, MD, Yale University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Pathologische processen
- Glucosemetabolismestoornissen
- Metabole ziekten
- Ziekten van de luchtwegen
- Longziekten
- Endocriene systeemziekten
- Baby, pasgeborene, ziekten
- Genetische ziekten, aangeboren
- Alvleesklier Ziekten
- Fibrose
- Suikerziekte
- Taaislijmziekte
- Fysiologische effecten van medicijnen
- Hypoglycemische middelen
Andere studie-ID-nummers
- 1409014580
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