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Trial record 23 of 23 for:    "Hyperinsulinism" | "Fenofibrate"

Aggressive Treatment of Metabolic Syndrome in Patients Receiving Clozapine for Schizophrenia (ATOMICS)

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: NCT00794963
Recruitment Status : Terminated (Difficulty recruiting)
First Posted : November 21, 2008
Results First Posted : November 18, 2011
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):
Peter Manu, Northwell Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metabolic Syndrome
Interventions Drug: Pravastatin, Fenofibrate, Metformin, Orlistat, irbesartan
Other: As selected by community physician
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Integrated Care Usual Care
Hide Arm/Group Description Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
Period Title: Overall Study
Started 4 4
Completed 3 0
Not Completed 1 4
Reason Not Completed
Withdrawal by Subject             1             4
Arm/Group Title Integrated Care Usual Care Total
Hide Arm/Group Description Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community Total of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
 100.0%
8
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 8 participants
53.7  (4.8) 43.5  (5.6) 48.6  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
1
  25.0%
0
   0.0%
1
  12.5%
Male
3
  75.0%
4
 100.0%
7
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 8 participants
4 4 8
1.Primary Outcome
Title Change in Weight
Hide Description [Not Specified]
Time Frame baseline and 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
4 participants in usual care arm did not return for follow-up and were not available for analysis; 1 participant in the integrated care group was lost to follow-up
Arm/Group Title Integrated Care Usual Care
Hide Arm/Group Description:
Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
Overall Number of Participants Analyzed 3 0
Mean (Standard Deviation)
Unit of Measure: pounds
11  (5.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Integrated Care Usual Care
Hide Arm/Group Description Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
All-Cause Mortality
Integrated Care Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Integrated Care Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Integrated Care Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Peter Manu, MD
Organization: North Shore Long Island Jewish Health System, Zucker Hillside Hospita, Glen Oaks, NY
Phone: 718 470-8290 pmanu@nshs.edu
Responsible Party: Peter Manu, Northwell Health
ClinicalTrials.gov Identifier: NCT00794963     History of Changes
Other Study ID Numbers: 08-177
First Submitted: November 19, 2008
First Posted: November 21, 2008
Results First Submitted: July 19, 2011
Results First Posted: November 18, 2011
Last Update Posted: April 15, 2015