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Lo studio clinico NCT01402037 per Diabete di tipo 1 è sconosciuto. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Beta Cell Function in (Pre)Type 1 Diabetes 100 Terapia cellulare Osservazionale
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La sperimentazione clinica NCT01402037 è uno studio interventistico per Diabete di tipo 1, attualmente sconosciuto. Avviato il 1 luglio 2011, prevede di arruolare 100 partecipanti. Sotto la guida di Universitair Ziekenhuis Brussel, dovrebbe concludersi entro il 1 luglio 2016. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 30 dicembre 2013.
Sommario breve
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...Mostra di più
Descrizione dettagliata
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...Mostra di più
Titolo ufficiale
Relation Between Residual Beta Cell Function and Glycemic Variability in (Pre) Type 1 Diabetes.
Patologie
Diabete di tipo 1Altri ID dello studio
- KD_BF_02
Numero NCT
Data di inizio (effettiva)
2011-07
Ultimo aggiornamento pubblicato
2013-12-30
Data di completamento (stimata)
2016-07
Arruolamento (previsto)
100
Tipo di studio
Interventistico
FASE
N.D.
Stato
Sconosciuto
Parole chiave
type 1 diabetes
Prevention
First degree relatives
High risk for type 1 diabetes
Prevention
First degree relatives
High risk for type 1 diabetes
Scopo principale
Diagnostico
Allocazione
Non randomizzato
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
AltroNDP 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...Mostra di più | Glucosio Glucose 20% intravenous Monitoraggio continuo del glucosio 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. |
AltroNDP 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. | Monitoraggio continuo del glucosio 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. |
AltroFDR 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...Mostra di più | Glucosio Glucose 20% intravenous Monitoraggio continuo del glucosio 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. |
AltroFDR 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. | Glucosio Glucose 20% intravenous Monitoraggio continuo del glucosio 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. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Criteri di eleggibilità
Età idonea
Bambino, Adulto
Età minima
5 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
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...
Parte responsabile dello studio
Bart Keymeulen, Investigatore principale, MD PhD, Universitair Ziekenhuis Brussel
Contatti principali dello studio
Contatto: Frans K Gorus, MD PhD, +32 2 477 50 31
Contatto: Ursule Van de Velde, +32 2 476 35 46, [email protected]
3 Centri dello studio in 1 paesi
UZ Brussels, Brussels, 1090, Belgium
Bart Keymeulen, MD PhD, Contatto, +32 2 477 61 11, [email protected]
Katelijn Decochez, MD PhD, Investigatore principale
In arruolamento
UZ Antwerpen, Edegem, 2650, Belgium
Christophe Deblock, MD. PhD., Contatto
Christophe Deblock, MD PhD, Investigatore principale
In arruolamento
UZ Gent, Ghent, 9000, Belgium
Johannes Ruige, MD PhD, Contatto, [email protected]
Johannes Ruige, MD PhD, Investigatore principale
In arruolamento