Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Metformin in Co-morbid Diabetes or Prediabetes and Serious Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02167620
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Margaret Hahn, Centre for Addiction and Mental Health

Brief Summary:
Schizophrenia is associated with a lifespan shortened by 20 years, due to cardiovascular disease (CVD), with antipsychotic (AP) medications understood to contribute to this risk through associated metabolic side-effects. Metformin, a medication used to treat prediabetes, and diabetes in the general population, holds promise with regard to reduction of AP-related metabolic problems, but has not been directly tested in early episode patients beyond weight loss, nor specifically in patients with diabetes or prediabetes and psychosis. We propose to replicate findings that metformin can reduce weight gain, and dysglycemia uniquely focusing on an early episode population diagnosed with prediabetes or diabetes. To help determine long-term risk/benefit of adjunctive metformin, we propose to look at changes in abdominal and liver fat, two well-established risk factors for CVD. Given links between dysglycemia, obesity with hippocampal volume loss and cognitive dysfunction, we will explore if improvements in metabolic indices are associated in changes in cognition and brain structure.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Schizophrenia Drug: Metformin Drug: Placebo Phase 4

Detailed Description:
This is a 16 week, double-blind, randomized pilot study, which proposes to recruit 24 patients with schizophrenia, or schizoaffective disorders (DSM 5), who are overweight or obese (BMI >25) and have prediabetes or type 2 diabetes. Randomization occurs on a 2:1 basis, with 16 patients randomised to metformin, and 8 to placebo. Metfomin/placebo is dispensed monthly. The baseline and /or screening visit includes a physical exam (including anthropometric measures), medical history, fasting blood work (glucose, insulin, HbA1c, lipids, electrolytes, thyroid, liver/kidney function), in addition to a urine drug screen. Women of child-bearing age are given a pregnancy test. Patients who meet inclusion criteria and consent to the study have an oral glucose tolerance test (OGTT), and a baseline abdominal and brain MRI (to respectively assess visceral adiposity, a key risk factor for CV disease, and hippocampal volumes). Anthropometric measures and pill counts are repeated bi-weekly. At week 8, fasting insulin/glucose, HbA1C, and liver function tests are measured. End of study measures (week 16), include the same panel of bloodwork conducted at baseline, as well as a repeat OGTT, and an abdominal and brain MRI. Rountine psychopathology scales, including BPRS, CGI, and CDS will be measured at baseline, and week 16. The Brief Assessment of Cognition in Schizophrenia (BACS) will also be completed at baseline, and study end.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Metformin in Co-morbid Diabetes or Prediabetes and Serious Mental Illness
Study Start Date : June 2014
Actual Primary Completion Date : February 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Metformin
Metformin/ placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.
Drug: Metformin
Metformin will be dispensed on a biweekly basis, and pill counts conducted at each visit.

Placebo Comparator: Placebo
Metformin/ placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.
Drug: Placebo
Placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.
Other Name: Sugar pill




Primary Outcome Measures :
  1. 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)) [ Time Frame: 3 years ]
    HbA1c value assessment


Secondary Outcome Measures :
  1. Decreases in visceral adiposity [ Time Frame: 3 years ]
    Visceral adiposity assessment via MRI

  2. Decreases in hepatic adiposity [ Time Frame: 3 years ]
    Hepatic adiposity assessment via MRI

  3. Greater than 5% decrease in body weight [ Time Frame: 3 years ]
    Body weight assessment

  4. Improvements in cognition [ Time Frame: 3 years ]
    Cognition assessment

  5. Improvements in hippocampal volume [ Time Frame: 3 years ]
    Cognition assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients within 5 years of diagnosis of schizophrenia, schizoaffective disorder , or bipolar disorder(DSM V), or those younger than 40 years old, regardless of duration of illness
  • Co-morbid diagnosis of prediabetes or diabetes (Canadian or American Diabetes Association criteria)

Exclusion Criteria:

  • Patients with co-morbid axis, other than nicotine dependence, or cannabis abuse
  • Patients with liver, or renal dysfunction,
  • Patients with a positive drug urine screen (other than cannabis or nicotine)
  • Females with a positive pregnancy test will be excluded.
  • Prior trial with metformin, and reported lack of tolerability
  • Patients with an A1C > 9.5%, or symptomatic hyperglycemia with metabolic decompensation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167620


Locations
Layout table for location information
Canada, Ontario
Center for Addiction and Mental Health
Toronto, Ontario, Canada
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Layout table for investigator information
Principal Investigator: Margaret Hahn Center for Addiction and Mental Health
Layout table for additonal information
Responsible Party: Margaret Hahn, Clinician/Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02167620    
Other Study ID Numbers: 007/2014
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Schizophrenia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs