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حالة التجربة السريرية NCT01851694 لـ التليف الكيسي، قصور البنكرياس هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
جامعة بنسلفانياBeta-cell Response to Incretin Hormones in Cystic Fibrosis ٤٥
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT01851694 هي دراسة تدخُّلية لـالتليف الكيسي، قصور البنكرياس وهي يقبل مشاركين. بدأت في ٢١ جمادى الآخرة ١٤٣٤ هـ مع خطة لتجنيد ٤٥ مشاركًا. يقودها جامعة بنسلفانيا، ومن المتوقع اكتمالها بحلول ٢١ جمادى الآخرة ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٥ رجب ١٤٤٧ هـ.
الملخص
In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when either the body does not make enough insulin or the body does not respond correctly to this insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar) from the food we eat to the cel...عرض المزيد
وصف مفصل
Previously, cystic fibrosis related diabetes (CFRD) was considered to be a consequence of damage to the pancreas therefore the cells contained in the pancreas--i.e.--islets that house beta cells, which make and release insulin (similar to T1D). Recent evidence suggests that other factors may also be associated that are similar to those with T2D. For example, patients with T2D, have decreased secretion of incretins, h...عرض المزيد
العنوان الرسمي
Determination of Beta-cell Responsiveness to the Incretin Hormones GLP-1 and GIP in Cystic Fibrosis
الحالات الطبية
التليف الكيسيقصور البنكرياسالمنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:معرّفات دراسة أخرى
- 817585
NCT معرّف
تاريخ البدء (فعلي)
2013-05
آخر تحديث مُنشور
2026-01-14
تاريخ الاكتمال (المقدر)
2026-12
عدد المشاركين المخطط لهم
٤٥
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
يقبل مشاركين
الكلمات الرئيسية
Cystic Fibrosis
Diabetes
Pancreatic insufficiency
Cystic Fibrosis with Normal Glucose Tolerance
Non-Cystic Fibrosis control group
Diabetes
Pancreatic insufficiency
Cystic Fibrosis with Normal Glucose Tolerance
Non-Cystic Fibrosis control group
الغرض الأساسي
أخرى
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
رباعي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةGLP-1 Incretin Hormone The incretin, Glucagon-Like-peptide-1 (GLP-1) will be infused into the veins starting 30 minutes prior to initiating the GPA test. This infusion will continue for a total of 90 mins. (during the GPA for 230 mg/dL glucose levels) and then this will be stopped. The GPA test will be performed for the 340 mg/dL glucose levels but no incretin will be infused during this part of the test. These data will be compared when t...عرض المزيد | GLP-1 Each subject in this arm will receive GLP-1 infusion and a placebo infusion during a GPA test. |
تجريبيةGIP Incretin Hormone The incretin, Glucose-dependent Insulinotropic Polypeptide (GIP) will be infused into the veins starting 30 minutes prior to initiating the GPA test. This infusion will continue for a total of 90 mins (during the GPA for 230 mg/dL glucose levels) and then this will be stopped. The GPA test will be performed for the 340 mg/dL glucose levels but no incretin will be infused during this part of the test. These data will ...عرض المزيد | GIP Each subject in this arm will receive GIP infusion and placebo during a GPA test. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Second-phase insulin response during GPA test | The key endpoint of interest will be the change in second phase insulin response derived from the Glucose-Potentiated Arginine (GPA) test. The GPA test will measure insulin (and other glucose controlling hormones) which will be a measure of pancreatic endocrine function in response to injection of arginine. Arginine is a naturally occurring amino acid (substance) in the body. It will be given in the veins to make the pancreas secrete insulin. After the first injection of arginine, a glucose infusion will be started in order to raise the level of sugar in the blood to 230 mg/dl. Once the level is achieved, arginine will be injected again and blood samples are measured. After a 2 hour break, the glucose infusion will be started to achieve a blood sugar of 340mg/dl and arginine injection will be repeated. Comparison of responses with incretin vs. placebo will be performed using statistical methods, specifically, paired t-test or Wilcoxon matched pair test. | 5 hours |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change in insulin secretion among CF groups | The change in second phase insulin secretion induced by incretins will be compared among the different subgroups of patients with CF (Ind-GT, IGT, and early CFRD) groups using nonparametric comparison of changes in slope, estimated using Mann-Whitney methods. | 5 hours |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
يقبل المتطوعين الأصحاء
نعم
- Confirmed diagnosis of cystic fibrosis, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria,
- Age greater than or equal to 18y on date of consent
- Pancreatic insufficiency
- Recent OGTT consistent with Indeterminate-GT, IGT, CFRD w/o fasting hyperglycemia, or an established diagnosis of CFRD without fasting hyperglycemia
- For female subjects, negative urine pregnancy test at enrollment.
Control Subjects:
- No history of cystic fibrosis.
- Age ≥ 18y on date of consent.
- Recent OGTT consistent with NGT.
- For female subjects, negative urine pregnancy test at enrollment.
- Established diagnosis of non-CF diabetes (i.e. T1D) or CFRD with fasting hyperglycemia (fasting glucose greater than126 mg/dL)
- History of clinically symptomatic pancreatitis within last year
- Prior lung or liver transplant
- Severe CF liver disease, as defined by portal hypertension
- Fundoplication-related dumping syndrome
- Medical co-morbidities that are not CF-related or are unstable per investigator opinion (i.e. history of bleeding disorders, immunodeficiency)
- Acute illness or changes in therapy (including antibiotics) within 6 weeks prior to study procedures
- Treatment with oral or intravenous corticosteroids within 6 weeks of study
- Hemoglobin less than10g/dL, within 90 days of Visit 1 or at Screening
- Abnormal renal function, within 90 days of Visit 1 or at Screening; defined as Creatinine greater than 2x upper limit of normal (ULN) or potassium greater than 5.5mEq/L on non-hemolyzed specimen
- Inability to perform study specific procedures (MMTT, GPA)
- Subjects, who in study team opinion, may be non-compliant with study procedures.
Control Subjects who will be exposed to GIP only:
- History of clinically symptomatic pancreatitis.
- History of liver disease.
- History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject.
- Hemoglobin <10g/dL, within 90 days of GPA test or at Screening.
- Abnormal renal function, within 90 days of GPA test or at Screening; defined as creatinine > 2x upper limit of normal (ULN) or potassium > 5.5mEq/L on non-hemolyzed specimen.
- Inability to perform study specific procedures (MMTT, GPA).
- subjects, who in study team opinion, may be non-compliant with study procedures.
- elevation of serum amylase or lipase > 1.5x ULN within 90 days of GPA test.
جامعة بنسلفانيا503 دراسات نشطة للاستكشافChildren's Hospital of Philadelphiaالجهة المسؤولة عن الدراسة
Michael R. Rickels, MD, MS, المحقق الرئيسي, Professor of Medicine, University of Pennsylvania
جهة اتصال مركزية للدراسة
جهة اتصال: Paola Alvarado, 215-746-2081, [email protected]
1 مواقع الدراسة في 1 بلدان
Pennsylvania
Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, Pennsylvania, 19060, United States
Paola Alvarado, جهة اتصال, 215-746-2081, [email protected]
Michael Rickels, M.D., M.S, المحقق الرئيسي
Andrea Kelly, M.D, M.S., المحقق الرئيسي
يقبل مشاركين