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Het effect van een DPP-4 remmer op de reactie van het lichaam bij een hypoglykemie bij patiënten met type 1 diabetes.

Dipeptidyl peptidase-4 inhibitors and Alpha-cell Recovery.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25642
Enrollment
16
Registered
2010-10-08
Start date
2011-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EN - NL Type 1 diabetes mellitus - type 1 diabetes mellitus Hypoglycaemia - hypoglykemie Glucagon - glucagon

Interventions

The 16 type 1 patients will be randomised to one of two treatment sequences: DPP-4 inhibitor followed by placebo or placebo followed by a DPP-4 inhibitor. Each treatment period lasts 6 weeks, so all p

Sponsors

Academic Medical Center, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male; 2. Age 18-40 years; 3. Type 1 Diabetes Mellitus 5-20 years duration; 4. C-peptide negative; 5. Willing and able to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Impaired awareness of hypoglycaemia; 2. BMI > 27 kg/m2; 3. Evidence of severe diabetes complications (autonomic neuropathy, macroalbuminuria, proliferative retinopathy); 4. Acute illness within 3 months before the study; 5. Significant renal impairment (creatinine clearance <50ml/min); 6. Use of beta-adrenoreceptor blockers; 7. Cardiac history (previous arrhythmia); 8. History of epilepsy.

Design outcomes

Primary

MeasureTime frame
Glucagon response to insulin induced hypoglycaemia measured as AUC (area under the curve).

Secondary

MeasureTime frame
1. Other counterregulatory hormone responses to insulin induced hypoglycaemia measured as AUC; 2. Symptomatic hormone responses to insulin induced hypoglycaemia.

Contacts

Public ContactF. Holleman

Postbus 22660

F.Holleman@amc.uva.nl+31 (0)20 5665954

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)