Beta Cell Function in (Pre)Type 1 Diabetes

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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 both variables over a broad range of residual function and will identify treatment goals for functional beta cell mass to be reached in future beta cell therapy trials in order to avoid frequent hypoglycemia in patients and dysglycemia in risk groups. The available expertise and infrastructure (see background and (inter)national context) place the promoters of the present project in a unique position to carry out the planned experiments and support their feasibility.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AZ-VUB
• Collaborators: University Hospital, Antwerp; University Hospital, Ghent; Vrije Universiteit Brussel

Criteria

Inclusion Criteria:

Type 1 diabetic patients:

1. aged 12-39 years at diagnosis

2. treated with insulin for less than 4 weeks

3. 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)

4. 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:

1. aged 12-39 years at inclusion

2. 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

3. > 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)

Exclusion Criteria:

• 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.