Trial Outcomes & Findings for Heart Rate Variability in Response to Metformin Challenge (NCT NCT02500628)

NCT ID: NCT02500628

Last Updated: 2018-01-03

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 61 participants
• Primary outcome timeframe: difference pre/post metformin ingestion (2 hours)
• Results posted on: 2018-01-03

Participant Flow

7/25/2015 to 2/21/16

Participant milestones

Measure	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
Overall Study STARTED	38	23
Overall Study COMPLETED	38	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Fibromyalgia n=38 Participants 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 n=23 Participants 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 n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=38 Participants	0 Participants n=23 Participants	0 Participants n=61 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=38 Participants	23 Participants n=23 Participants	60 Participants n=61 Participants
Age, Categorical >=65 years	1 Participants n=38 Participants	0 Participants n=23 Participants	1 Participants n=61 Participants
Age, Continuous	46.71 years STANDARD_DEVIATION 12.15 • n=38 Participants	47.61 years STANDARD_DEVIATION 11.9 • n=23 Participants	47.1 years STANDARD_DEVIATION 12.32 • n=61 Participants
Sex: Female, Male Female	31 Participants n=38 Participants	20 Participants n=23 Participants	51 Participants n=61 Participants
Sex: Female, Male Male	7 Participants n=38 Participants	3 Participants n=23 Participants	10 Participants n=61 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	38 Participants n=38 Participants	23 Participants n=23 Participants	61 Participants n=61 Participants

PRIMARY outcome

Timeframe: difference pre/post metformin ingestion (2 hours)

Population: Patients with or without fibromyalgia, with or without antipsychotic use.

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)

Outcome measures

Measure	Fibromyalgia n=38 Participants 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 n=23 Participants 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
Heart Rate Variability (Time Domain)	0.92 msec/msec Standard Deviation 0.31	0.83 msec/msec Standard Deviation 0.32

PRIMARY outcome

Timeframe: difference pre/post metformin ingestion (2 hours)

Population: patients with or without fibromyalgia. with or without antipsychotic use

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.

Outcome measures

Measure	Fibromyalgia n=38 Participants 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 n=23 Participants 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
Heart Rate Variability (Frequency Domain)	-.14 ratio Standard Deviation 0.29	-.24 ratio Standard Deviation 0.38

SECONDARY outcome

Timeframe: 2 hours after ingestion

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

Outcome measures

Measure	Fibromyalgia n=38 Participants 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 n=23 Participants 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
Number of Patients Reporting Side Effects From the Medication	13 Participants	9 Participants

Adverse Events

Fibromyalgia

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Antipsychotic Use

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fibromyalgia n=38 participants at risk 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 n=23 participants at risk 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
Gastrointestinal disorders GI distress	13.2% 5/38 • Number of events 5 • 2 hours after ingestion of metformin 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	8.7% 2/23 • Number of events 2 • 2 hours after ingestion of metformin 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
Nervous system disorders drowsiness	21.1% 8/38 • Number of events 8 • 2 hours after ingestion of metformin 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	30.4% 7/23 • Number of events 7 • 2 hours after ingestion of metformin 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

Additional Information

Jon Berner MD PhD

Woodinville Psychiatric Associates

Phone: 425-481-0429

Email: jonbernermd@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place