NCT02500628

Brief Summary

Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then provide an additional sample 2 hours later.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 3, 2018

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

7 months

First QC Date

July 11, 2015

Results QC Date

May 29, 2017

Last Update Submit

December 30, 2017

Conditions

FibromyalgiaMitochondrial DiseasesMovement DisordersDiabetes Mellitus, Type 2

Keywords

metforminmitochondriacomplex 1fibromyalgianeurogenic paindiabetestardive dyskinesiaheart rate variability

Outcome Measures

Primary Outcomes (2)

  • Heart Rate Variability (Time Domain)

    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)

    difference pre/post metformin ingestion (2 hours)

  • Heart Rate Variability (Frequency Domain)

    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.

    difference pre/post metformin ingestion (2 hours)

Secondary Outcomes (1)

  • Number of Patients Reporting Side Effects From the Medication

    2 hours after ingestion

Study Arms (2)

Fibromyalgia

EXPERIMENTAL

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

Drug: Metformin

Antipsychotic use

EXPERIMENTAL

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

Drug: Metformin

Interventions

MetforminDRUG

500 mg orally after baseline testing of heart rate

Also known as: Glucophage
Antipsychotic useFibromyalgia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • EITHER chronic neurogenic pain meeting American College of Rheumatology criteria for fibromyalgia or previous/current exposure to antipsychotic medications

You may not qualify if:

  • recent infection,
  • renal failure,
  • pre-existing cardiac disease,
  • chronic obstructive pulmonary disease
  • inability to participate in informed consent,
  • lack of transport to return home from study site,
  • severe fasting intolerance or hypoglycemia,
  • history of stroke-alike episode,
  • uncontrolled migraine or cyclic vomiting,
  • diabetes on insulin or sulfonylurea,
  • non-English speaker,
  • medications with strong effects on baseline heart rate variability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woodinville Psychiatric Associates

Woodinville, Washington, 98072, United States

Location

MeSH Terms

Conditions

FibromyalgiaMitochondrial DiseasesMovement DisordersDiabetes Mellitus, Type 2Diabetes MellitusTardive Dyskinesia

Interventions

Metformin

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCentral Nervous System DiseasesGlucose Metabolism DisordersEndocrine System DiseasesDyskinesia, Drug-InducedDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Jon Berner MD PhD
Organization
Woodinville Psychiatric Associates
jonbernermd@gmail.com
425-481-0429

Study Officials

  • Jon E Berner, MD PhD

    Woodinville Psychiatric Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinic Director

Study Record Dates

First Submitted

July 11, 2015

First Posted

July 16, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

January 3, 2018

Results First Posted

January 3, 2018

Record last verified: 2017-12

Locations

US(1)