Diabetes type 1 insulin-dependent diabetes juvenile diabetes
Conditions
Interventions
patients will be treated on a daily basis with capsules containing lyophilized
autologous faecal matter for a period of 6 months. During the screening period
participants will collect their stool, w
Sponsors
Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Male or female recently diagnosed (
Exclusion criteria
Exclusion criteria: 1. Major systemic illness 2. (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic chemotherapy or human immunodeficiency virus (HIV) infection with a CD4 count =3 stools/day for >4 weeks), chronic obstipation (3 months) or Inflammatory Bowel Disease (IBD). 4. Illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period. 5. Use of >21 units of alcohol per week on average in the past three months. 6. Pregnancy or breast feeding. 7. Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preservation of residual beta cell function (insulin secretion capacity) Residual beta cell function will be determined as stimulated C-peptide release during two hours (AUC0-120min) upon an MMT. The MMT will be performed during every visit at 0,6 and 12 months. C-peptide concentrations will be presented as pmol/ml. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycaemic control Toinvestigate overt effectsofthe intervention on glycaemic control we will collect fasting blood for determinationofglucose,HbA1c,lipid spectrum,liver and kidney function (eGFR). Albumin will be measured in urine (microalbuminuria).Inaddition,we will read-out participants continuous glucose monitoring device (Freestyle Libre)fortheir time in range and hyper- and hypo glycaemic episodes and we will record the exogenous insulin dose use. Above measurements will be performed during every visit at 0,6 and 12 months. Questionnaires and dietary intake At each study visit questionnaires will be completed determine changes in: - Diabetic complications, hypoglycaemie episodes, insulin dosages and medication changes - Gastro-intestinal complaints - Dietary intake 3 days prior to visit | — |
Countries
Netherlands
Outcome results
None listed