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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
Enrollment 61
Recruitment Details 7/25/2015 to 2/21/16
Pre-assignment Details  
Arm/Group Title Fibromyalgia Antipsychotic Use
Hide Arm/Group Description

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

Metformin: 500 mg orally after baseline testing of heart rate

Period Title: Overall Study
Started 38 23
Completed 38 23
Not Completed 0 0
Arm/Group Title Fibromyalgia Antipsychotic Use Total
Hide Arm/Group Description

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

Metformin: 500 mg po after baseline testing of heart rate

Total of all reporting groups
Overall Number of Baseline Participants 38 23 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 23 participants 61 participants
<=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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 23 participants 61 participants
46.71  (12.15) 47.61  (11.9) 47.1  (12.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 23 participants 61 participants
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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 38 participants 23 participants 61 participants
38
 100.0%
23
 100.0%
61
 100.0%
1.Primary Outcome
Title Heart Rate Variability (Time Domain)
Hide Description ratio of the standard deviation of sampled intervals between each heart beat for ten minutes at time 1 (prior to metformin ingestion) over standard deviation of the sampled intervals between each heart beat for ten minutes at time 2 (2 hours post metformin ingestion)
Time Frame difference pre/post metformin ingestion (2 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with or without fibromyalgia, with or without antipsychotic use.
Arm/Group Title Fibromyalgia Antipsychotic Use
Hide Arm/Group Description:

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

Metformin: 500 mg po after baseline testing of heart rate

Overall Number of Participants Analyzed 38 23
Mean (Standard Deviation)
Unit of Measure: msec/msec
0.92  (0.31) 0.83  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fibromyalgia, Antipsychotic Use
Comments comparison between fibromyalgia and non-fibromyalgia group
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Heart Rate Variability (Frequency Domain)
Hide Description total power in the frequency domain is estimated for 10 minutes prior to metformin ingestion and then divided by the total power in the frequency domain estimated for 10 minutes 2 hours after metformin ingestion. Ratio is log-transformed.
Time Frame difference pre/post metformin ingestion (2 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
patients with or without fibromyalgia. with or without antipsychotic use
Arm/Group Title Fibromyalgia Antipsychotic Use
Hide Arm/Group Description:

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

Metformin: 500 mg orally after baseline testing of heart rate

Overall Number of Participants Analyzed 38 23
Mean (Standard Deviation)
Unit of Measure: ratio
-.14  (0.29) -.24  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fibromyalgia, Antipsychotic Use
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients Reporting Side Effects From the Medication
Hide Description Patient after testing generated an unprompted list of observed side effects from the medication. Many reported none. Results were scored as the binary presence or absence of side effect
Time Frame 2 hours after ingestion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fibromyalgia Antipsychotic Use
Hide Arm/Group Description:

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

Metformin: 500 mg po after baseline testing of heart rate

Overall Number of Participants Analyzed 38 23
Measure Type: Count of Participants
Unit of Measure: Participants
13
  34.2%
9
  39.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fibromyalgia
Comments difference between fibromyalgia and non-fibromyalgia patients.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 2 hours after ingestion of metformin
Adverse Event Reporting Description Patients provide an unstructured summary of possible side effects. Most reported none. Common side effects of GI distress or somnolence were scored as binary presence or absence
 
Arm/Group Title Fibromyalgia Antipsychotic Use
Hide Arm/Group Description

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

Metformin: 500 mg po after baseline testing of heart rate

All-Cause Mortality
Fibromyalgia Antipsychotic Use
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)      0/23 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Fibromyalgia Antipsychotic Use
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/23 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fibromyalgia Antipsychotic Use
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/38 (34.21%)      9/23 (39.13%)    
Gastrointestinal disorders     
GI distress * [1]  5/38 (13.16%)  5 2/23 (8.70%)  2
Nervous system disorders     
drowsiness *  8/38 (21.05%)  8 7/23 (30.43%)  7
*
Indicates events were collected by non-systematic assessment
[1]
Nausea
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
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