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Clinical Trial NCT01402037 for Type 1 Diabetes is unknown status. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Beta Cell Function in (Pre)Type 1 Diabetes 100 Cell Therapy Observational
Clinical Trial NCT01402037 is an interventional study for Type 1 Diabetes that is unknown status. It started on 1 July 2011 with plans to enroll 100 participants. Led by Universitair Ziekenhuis Brussel, it is expected to complete by 1 July 2016. The latest data from ClinicalTrials.gov was last updated on 30 December 2013.
Brief Summary
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...Show More
Detailed Description
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...Show More
Official Title
Relation Between Residual Beta Cell Function and Glycemic Variability in (Pre) Type 1 Diabetes.
Conditions
Type 1 DiabetesOther Study IDs
- KD_BF_02
NCT ID Number
Start Date (Actual)
2011-07
Last Update Posted
2013-12-30
Completion Date (Estimated)
2016-07
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Unknown status
Keywords
type 1 diabetes
Prevention
First degree relatives
High risk for type 1 diabetes
Prevention
First degree relatives
High risk for type 1 diabetes
Primary Purpose
Diagnostic
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherNDP 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...Show More | Glucose Glucose 20% intravenous Continuous glucose monitoring 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. |
OtherNDP 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. | Continuous glucose monitoring 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. |
OtherFDR 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...Show More | Glucose Glucose 20% intravenous Continuous glucose monitoring 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. |
OtherFDR 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. | Glucose Glucose 20% intravenous Continuous glucose monitoring 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
5 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
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...
Study Responsible Party
Bart Keymeulen, Principal Investigator, MD PhD, Universitair Ziekenhuis Brussel
Study Central Contact
Contact: Frans K Gorus, MD PhD, +32 2 477 50 31
Contact: Ursule Van de Velde, +32 2 476 35 46, [email protected]
3 Study Locations in 1 Countries
UZ Brussels, Brussels, 1090, Belgium
Bart Keymeulen, MD PhD, Contact, +32 2 477 61 11, [email protected]
Katelijn Decochez, MD PhD, Principal Investigator
Recruiting
UZ Antwerpen, Edegem, 2650, Belgium
Christophe Deblock, MD. PhD., Contact
Christophe Deblock, MD PhD, Principal Investigator
Recruiting
UZ Gent, Ghent, 9000, Belgium
Johannes Ruige, MD PhD, Contact, [email protected]
Johannes Ruige, MD PhD, Principal Investigator
Recruiting