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Heart Rate Variability in Response to Metformin Challenge

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ClinicalTrials.gov Identifier: NCT02500628
Recruitment Status : Completed
First Posted : July 16, 2015
Results First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Jon Berner MD PhD, Woodinville Psychiatric Associates

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Fibromyalgia
Mitochondrial Diseases
Movement Disorders
Diabetes Mellitus, Type 2
Intervention: Drug: Metformin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
7/25/2015 to 2/21/16

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fibromyalgia

Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg orally in the morning

Metformin: 500 mg orally after baseline testing of heart rate

Antipsychotic Use

Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg orally in the morning

Metformin: 500 mg orally after baseline testing of heart rate


Participant Flow:   Overall Study
    Fibromyalgia   Antipsychotic Use
STARTED   38   23 
COMPLETED   38   23 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fibromyalgia

Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM

Metformin: 500 mg po after baseline testing of heart rate

Antipsychotic Use

Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM

Metformin: 500 mg po after baseline testing of heart rate

Total Total of all reporting groups

Baseline Measures
   Fibromyalgia   Antipsychotic Use   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   23   61 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed   38   23   61 
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      37  97.4%      23 100.0%      60  98.4% 
>=65 years      1   2.6%      0   0.0%      1   1.6% 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   38   23   61 
   46.71  (12.15)   47.61  (11.9)   47.1  (12.32) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   38   23   61 
Female      31  81.6%      20  87.0%      51  83.6% 
Male      7  18.4%      3  13.0%      10  16.4% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States       
Participants Analyzed   38   23   61 
United States   38   23   61 


  Outcome Measures

1.  Primary:   Heart Rate Variability (Time Domain)   [ Time Frame: difference pre/post metformin ingestion (2 hours) ]

2.  Primary:   Heart Rate Variability (Frequency Domain)   [ Time Frame: difference pre/post metformin ingestion (2 hours) ]

3.  Secondary:   Number of Patients Reporting Side Effects From the Medication   [ Time Frame: 2 hours after ingestion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jon Berner MD PhD
Organization: Woodinville Psychiatric Associates
phone: 425-481-0429
e-mail: jonbernermd@gmail.com



Responsible Party: Jon Berner MD PhD, Woodinville Psychiatric Associates
ClinicalTrials.gov Identifier: NCT02500628     History of Changes
Other Study ID Numbers: 20150618
First Submitted: July 11, 2015
First Posted: July 16, 2015
Results First Submitted: May 29, 2017
Results First Posted: January 3, 2018
Last Update Posted: January 3, 2018