|- candidate number||3274|
|- NTR Number||NTR1313|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-mei-2008|
|- Secondary IDs||08-005 METC Zuidwest Holland|
|- Public Title||Oral glucose tolerance test with prolonged determination of glucose, insulin and C-peptide levels in patients with Cystic Fibrosis|
|- Scientific Title||Oral glucose tolerance test with prolonged determination of glucose, insulin and C-peptide levels in patients with Cystic Fibrosis|
|- ACRONYM||Prolonged OGTT in patients with CF|
|- Healt Condition(s) or Problem(s) studied||Cystic Fibrosis (CF), Diabetes Mellitus, Oral glucose tolerance test, Insuline|
|- Inclusion criteria||1. Cystic Fibrosis patients |
2. Proven diagnosis cystic fibrosis: either positive genotyping or raised sweat sodium
3. > 18 years
4. Stable disease
5. Regularly attending outpatients clinic
|- Exclusion criteria||1. Absent oral glucose tolerance test in last half year|
2. Cystic fibrosis-related diabetes diagnosis
3. Organ tranplantation in history
5. Current use of medications interfering with glucose tolerance
6. Current or recent pulmonary exacerbation requiring oral or intravenous antibiotics in the past 4 weeks
7. Medical conditions other than cystic fibrosis interfering with glucose tolerance
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jun-2008|
|- planned closingdate||31-dec-2008|
|- Target number of participants||18|
|- Interventions||All subjects included into this study will be administered in the hospital after three days of high carbohydrate intake and an overnight fasting of at least 8 hours. Subjects will be questioned about their present clinical status. In all subjects temperature, pulses and blood pressure will be determined. |
After a 15-min period of acclimatizing, a venflon is placed in an antecubital vein. A glucose solution of 1,75 gr/kg with a maximum of 75 grams of glucose is orally administered to the subjects. Blood samples of 4,0 ml each in a serum tube are taken on pre-set times, i.e. -5, 0, 30, 60, 90, 120, 150, 180, 240, and 300 min after administering the glucose solution.
Patients stay sober during the total scope of the study.
|- Primary outcome||Blood glucose levels, blood insulin levels and blood C-peptide levels during OGTT and after OGTT during a follow-up period of 3 hours.|
|- Secondary outcome||Insulin resistance and ß-cell function, calculated respectively by HOMA-IR and
Areas under the curve for glucose, insulin and c-peptide levels.
Peak glucose levels.
|- Timepoints||The study period for the individual patient comprises one outpatient visit of 6 hours.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD J.M.W. Berg, van den|
|- CONTACT for SCIENTIFIC QUERIES||MD J.M.W. Berg, van den|
|- Sponsor/Initiator ||Haga Teaching Hospital, Department of Pulmonology|
(Source(s) of Monetary or Material Support)
|Haga Teaching Hospital, Department of Pulmonology|
|- Brief summary||Rationale: In literature the value of early diabetic therapy in patients with Cystic Fibrosis (CF) developing diabetes is considered of major interest. Still, no consensus is available on the optimal diabetic treatment of CF patients with either a normal or impaired glucose tolerance. To get more insight in the exact glucose levels and the total insulin secretion, as well as to determine the optimal time of measurement peak glucose levels we would like to perform prolonged oral glucose tolerance test (OGTT) with insulin and C-peptide measurements in these patients, from what areas under the curve, insulin resistance and ß-cell function will be calculated
Objective: Investigate the exact glucose levels during a two hour OGTT and a follow-up period of three hours. At the same time, insulin and C-peptide levels are determined to get more insight in the total insulin secretion.|
Study design: Prospective clinical comparing experiment with defined patient populations.
Study population: The patient population comprises 6 adult CF patients with exocrine pancreas sufficiency, 6 adult CF patients with exocrine pancreas insufficiency and a normal glucose tolerance, and 6 adult CF patients with exocrine pancreas insufficiency and an impaired glucose tolerance.
Main study parameters/endpoints: Blood glucose levels and blood insulin levels and blood C-peptide levels during an 2 hour OGTT and during a follow-up period of 3 hours. Samples are taken on pre-set times.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will have to visit our clinic one time in the total scope of this study. At this visit, they will undergo physical examination by determination of body temperature, blood pressure and pulses and will be questioned about their present clinical status. A venflon is placed in an antecubital vein and will stay in place during the total 5 hours. During this period of 5 hours, subjects have to stay sober. A total of 10 blood samples of each 4,0 ml will be taken.
|- Main changes (audit trail)|
|- RECORD||8-mei-2008 - 19-mei-2008|