| Trial ID: | L3080 |
| Source ID: | NCT02167620
|
| Associated Drug: |
Metformin
|
| Title: |
Metformin in Co-morbid Diabetes or Prediabetes and Serious Mental Illness
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Schizophrenia
|
| Interventions: |
DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Improvement in HbA1C derived from Oral glucose tolerance test (Matsuda, index of insulin sensitivity; area under glucose curve; insulin secretion sensitivity index-2 (ISSI-2)), HbA1c value assessment, 3 years | Secondary: Decreases in visceral adiposity, Visceral adiposity assessment via MRI, 3 years|Decreases in hepatic adiposity, Hepatic adiposity assessment via MRI, 3 years|Greater than 5% decrease in body weight, Body weight assessment, 3 years|Improvements in cognition, Cognition assessment, 3 years|Improvements in hippocampal volume, Cognition assessment, 3 years
|
| Sponsor/Collaborators: |
Sponsor: Centre for Addiction and Mental Health
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
35
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-06
|
| Completion Date: |
2018-03
|
| Results First Posted: |
|
| Last Update Posted: |
2018-07-30
|
| Locations: |
Center for Addiction and Mental Health, Toronto, Ontario, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02167620
|
