Heart Rate Variability in Response to Metformin Challenge

NCT ID: NCT02500628

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-02-29

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.

Detailed Description

Doctors need to develop tests which inexpensively and reliably evaluates brain metabolism. Current diagnostic tests sample other tissues which often run on different fuels (fats), utilize unproven and often insensitive brain imaging scanners, or sequence thousands to millions of base-pairs of DNA. All of these tests are expensive. None of these tests accurately or completely capture the interactions between the 1000s of proteins involved in brain metabolism.

The investigators suspect that mathematical analysis of the resting heart rate may provide some insight into brain metabolism. The brain controls heart rate in response to changes in blood pressure and blood gases like carbon dioxide and oxygen. Tight control of heart rate is necessary to make sure that the brain has the right mix of fuel and air. Because the brain can't respond instantly to changes in its fuel supply, this system acting as a biological carburetor has a natural oscillatory rhythm that can be monitored just like frequencies on the radio.

The investigators propose to amplify these rhythms by modestly metabolically stressing the brain with metformin, a inhibitor of complex 1 in the mitochondria.

Conditions

Fibromyalgia; Mitochondrial Diseases; Movement Disorders; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fibromyalgia

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

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

500 mg orally after baseline testing of heart rate

Interventions

Metformin

500 mg orally after baseline testing of heart rate

Intervention Type: DRUG

Other Intervention Names

Glucophage

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Woodinville Psychiatric Associates

OTHER

Sponsor Role: lead

Responsible Party

Jon Berner MD PhD

Clinic Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jon E Berner, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Woodinville Psychiatric Associates

Locations

Woodinville Psychiatric Associates

Woodinville, Washington, United States

Countries

United States

Other Identifiers

20150618

Identifier Type: -

Identifier Source: org_study_id