| Trial ID: | L6405 |
| Source ID: | NCT02881528
|
| Associated Drug: |
Metformin Hydrochloride
|
| Title: |
Autoimmune Diabetes Accelerator Prevention Trial
|
| Acronym: |
adAPT
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Prediabetic State
|
| Interventions: |
DRUG: Metformin Hydrochloride|DRUG: Placebo
|
| Outcome Measures: |
Primary: Between group difference in reduction of Homeostatic Model Assessment (HOMAR) of Insulin Resistance (IR, mass units)., Note: study not powered to nominate a primary outcome as feasibility study., 21 months (Stage1)|Between group difference in reduction in beta cell demand as measured by serum glucose (mmol/L) and C-peptide (ng/mL), Note: study not powered to nominate a primary outcome as feasibility study., 21 months | Secondary: Feasibility of a randomized controlled trial in children who are at high risk of T1D as measured by recruitment rates (%), 21 months|Feasibility of a randomized controlled trial in children who are at high risk of T1D as measured by attrition rates (%), 21 months | Other: Percentage response rate of families who choose to participate in the intervention stage when a second sibling in the same family is found to be at high risk of T1D., Calculate the response rate of those identified as double antigen positive and decide to participate in the RCT phase of the study., 21 months|Compliance with study medication., Adherence measured as a percentage of prescribed doses., 21 months (Stage1)|Between group difference in serum vitamin B12, 21 months (Stage1)|Between group difference in Immunological t-cell response to diabetes, 21 months
|
| Sponsor/Collaborators: |
Sponsor: University of Exeter | Collaborators: University of Dundee|University of Bristol
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE4
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2016-03-30
|
| Completion Date: |
2017-12-22
|
| Results First Posted: |
|
| Last Update Posted: |
2018-10-16
|
| Locations: |
NHS Ayrshire & Arran, Kilmarnock, Ayrshire, KA2 0BE, United Kingdom|NHS Grampian, Aberdeen, Grampian, AB25 2ZG, United Kingdom|NHS Lanarkshire, Wishaw, Lanarkshire, ML2 0DP, United Kingdom|NHS Tayside, Dundee, Tayside, DD1 9SY, United Kingdom|NHS Greater Glasgow & Clyde, Glasgow, G3 8SJ, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02881528
|
