Heart Rate Variability in Response to Metformin Challenge

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Heart Rate Variability in Response to Metformin Challenge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500628
• Other study ID #: 20150618
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2015
• Last updated: December 30, 2017
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: December 2017
• Source: Woodinville Psychiatric Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fibromyalgia
• Mitochondrial Diseases
• Movement Disorders
• Myofascial Pain Syndromes

Intervention

Drug:
• Metformin
500 mg orally after baseline testing of heart rate

Locations

Country	Name	City	State
United States	Woodinville Psychiatric Associates	Woodinville	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Woodinville Psychiatric Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Number of Patients Reporting Side Effects From the Medication	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	2 hours after ingestion