رادار التجارب AI | ||
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حالة التجربة السريرية NCT01402037 لـ داء السكري من النوع 1 هي غير معروف. 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
Beta Cell Function in (Pre)Type 1 Diabetes ١٠٠ علاج خلوي رصدية
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 NCT01402037 هي دراسة تدخُّلية لـداء السكري من النوع 1 وهي غير معروف. بدأت في ٢٩ رجب ١٤٣٢ هـ مع خطة لتجنيد ١٠٠ مشاركًا. يقودها Universitair Ziekenhuis Brussel، ومن المتوقع اكتمالها بحلول ٢٦ رمضان ١٤٣٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٧ صفر ١٤٣٥ هـ.
الملخص
Increased glycemic variability has been proposed as an independent predictor of hypoglycemia in diabetic patients. Likewise, episodes of dysglycemia have been found to be predictive of diabetes in antibodypositive nondiabetic individuals. We hypothesise that an in-depth observational study comparing state-of-the-art measures of functional beta cell mass and glycemic variability will specify the relationship between b...عرض المزيد
وصف مفصل
The established clinical network and the developed dynamic function tests and biological markers provide us with the unique opportunity to identify sufficiently large groups of high-risk first-degree relatives (> 50% risk of diabetes) of a proband with type 1 diabetes and of recent-onset type 1 diabetic patients with the overall aim to investigate the correlation between functional beta cell mass and glycemic variab...عرض المزيد
العنوان الرسمي
Relation Between Residual Beta Cell Function and Glycemic Variability in (Pre) Type 1 Diabetes.
الحالات الطبية
داء السكري من النوع 1معرّفات دراسة أخرى
- KD_BF_02
NCT معرّف
تاريخ البدء (فعلي)
2011-07
آخر تحديث مُنشور
2013-12-30
تاريخ الاكتمال (المقدر)
2016-07
عدد المشاركين المخطط لهم
١٠٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
غير معروف
الكلمات الرئيسية
type 1 diabetes
Prevention
First degree relatives
High risk for type 1 diabetes
Prevention
First degree relatives
High risk for type 1 diabetes
الغرض الأساسي
تشخيصي
طريقة توزيع المشاركين
غير عشوائي
نموذج التدخل
المجموعة الواحدة
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
أخرىNDP 12-39 y In newly diagnosed patients a hyperglycemic clamp tests will be performed within 4 weeks after diagnosis and 6, 12, 18 and 24 months later in 40 patients. The clamp will not be carried out in participants who became Cpeptide negative (defined as AUC C-peptide ≤ 0.03 nmol/L x min.) at a previous visit. HbA1c will be determined at the day of the clamp and glycemic variability during 5 days starting immediately after th...عرض المزيد | الجلوكوز Glucose 20% intravenous مراقبة الجلوكوز المستمرة Blood glucose profiles: during 5 days glucose profiles will be determined by seven-point self-monitoring of blood glucose (SMBG) (pre-breakfast: assumed time 7 am, post-breakfast: 8.30 am, pre-lunch: 12 am, post-lunch: 1.30 pm, pre-supper: 6 am, post-supper: 7.30 pm, bedtime: 10 pm) and by continuous glucose monitoring (CGM). Participants will be blinded for the CGM results. |
أخرىNDP 5-12 y Ten childhood-onset patients (under age 12) will be tested for 5 days with CGM (without clamp) and their glycemic variability compared with that of 10 patients aged 12-17 years at diagnosis. | مراقبة الجلوكوز المستمرة Blood glucose profiles: during 5 days glucose profiles will be determined by seven-point self-monitoring of blood glucose (SMBG) (pre-breakfast: assumed time 7 am, post-breakfast: 8.30 am, pre-lunch: 12 am, post-lunch: 1.30 pm, pre-supper: 6 am, post-supper: 7.30 pm, bedtime: 10 pm) and by continuous glucose monitoring (CGM). Participants will be blinded for the CGM results. |
أخرىFDR 12-39 y In first degree relatives of type 1 diabetes patients a hyperglycemic clamp tests will be performed at inclusion and 6, 12, 18 and 24 months later in 40 high-risk first-degree relatives (see previous definition) with a non-diabetic OGTT performed 1 to 2 weeks before the clamp procedure. An OGTT result suggestive of diabetes will be confirmed and the relative will be offered participation in the patient arm of the stu...عرض المزيد | الجلوكوز Glucose 20% intravenous مراقبة الجلوكوز المستمرة Blood glucose profiles: during 5 days glucose profiles will be determined by seven-point self-monitoring of blood glucose (SMBG) (pre-breakfast: assumed time 7 am, post-breakfast: 8.30 am, pre-lunch: 12 am, post-lunch: 1.30 pm, pre-supper: 6 am, post-supper: 7.30 pm, bedtime: 10 pm) and by continuous glucose monitoring (CGM). Participants will be blinded for the CGM results. |
أخرىFDR 5-12 y Ten high-risk first-degree relatives (see criteria) aged 5 to 12 years will also be tested for CGM and their results correlated with beta-cell function derived from a "mini-clamp" procedure (first 10 min. C-peptide release in hyperglycemic clamp) and results (CGM and first clamp phase) from relatives aged 12-17 years. | الجلوكوز Glucose 20% intravenous مراقبة الجلوكوز المستمرة Blood glucose profiles: during 5 days glucose profiles will be determined by seven-point self-monitoring of blood glucose (SMBG) (pre-breakfast: assumed time 7 am, post-breakfast: 8.30 am, pre-lunch: 12 am, post-lunch: 1.30 pm, pre-supper: 6 am, post-supper: 7.30 pm, bedtime: 10 pm) and by continuous glucose monitoring (CGM). Participants will be blinded for the CGM results. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
evaluate the hyperglycemic clamp to measure the functional beta cell mass test | to measure the functional beta cell mass of participants as determined by AUC C-peptide release during hyperglycemic clamp test | 2 years |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Follow up of OGTT's and HbA1c levels in high risk first degree relatives and patients | 2\) perform oral glucose tolerance tests (OGTTs; only in relatives), determine HbA1c levels centrally (relatives and patients) and record insulin requirements and hypoglycemic episodes (in patients) | 2 years |
evaluate the continuous glucose monitoring to measure within- and between-day glycemic variability | to measure within- and between-day glycemic variability as determined by seven point selfmonitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM) during 5 days preceding each clamp procedure | 2 years |
معايير الأهلية
الأعمار المؤهلة للدراسة
طفل, بالغ
العمر الأدنى للدراسة
5 Years
الجنس المؤهل
الكل
يقبل المتطوعين الأصحاء
نعم
Type 1 diabetic patients:
- aged 12-39 years at diagnosis
- treated with insulin for less than 4 weeks
- optimally treated with intensified insulin treatment: minimal three preprandial injections of ultra-rapidly acting analogs and one evening injection of long-acting insulin (Lantus®, Sanofi Aventis)
- positive for autoantibodies against insulin (IAA-sampled within the first week of insulin treatment), 65kDa glutamate decarboxylase (GADA), IA-2 protein (IA-2A) and/or zinc transporter 8 (ZnT8A)
First-degree relatives:
- aged 12-39 years at inclusion
- sibling or offspring of a type 1 diabetic patient diagnosed before age 35 or between age 35 and 50 with in addition a body mass index < 28 kg/m2 and an initial insulin dose > 0.25 U.kg -1.d-1
- > 50% risk of diabetes within 5 years as indicated by positivity for at least 2 diabetes antibodies including IA-2A and/or ZnT8A in absence of protective HLA-DQ genotypes (6)
- pregnancy or lactation in women
- use of illicit drugs or overconsumption of alcohol or history of drug or alcohol abuse
- being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders
- having received antidepressant medications during the last 6 months
- treatment with immune modulating or diabetogenic medication (such as corticosteroids)
- history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the subjects
- patients not treated with Lantus as insulin therapy.
Universitair Ziekenhuis Brussel- 🎓Vr...
الجهة المسؤولة عن الدراسة
Bart Keymeulen, المحقق الرئيسي, MD PhD, Universitair Ziekenhuis Brussel
جهة اتصال مركزية للدراسة
جهة اتصال: Frans K Gorus, MD PhD, +32 2 477 50 31
جهة اتصال: Ursule Van de Velde, +32 2 476 35 46, [email protected]
3 مواقع الدراسة في 1 بلدان
UZ Brussels, Brussels, 1090, Belgium
Bart Keymeulen, MD PhD, جهة اتصال, +32 2 477 61 11, [email protected]
Katelijn Decochez, MD PhD, المحقق الرئيسي
يقبل مشاركين
UZ Antwerpen, Edegem, 2650, Belgium
Christophe Deblock, MD. PhD., جهة اتصال
Christophe Deblock, MD PhD, المحقق الرئيسي
يقبل مشاركين
UZ Gent, Ghent, 9000, Belgium
Johannes Ruige, MD PhD, جهة اتصال, [email protected]
Johannes Ruige, MD PhD, المحقق الرئيسي
يقبل مشاركين