Trial Outcomes & Findings for Effects of Niacin on Intramyocellular Fatty Acid Trafficking in Upper Body Obesity and Type 2 Diabetes Mellitus (NCT NCT03867500)

Last Updated: 2025-01-17

Results Overview

Glucose infusion rates will be measured in upper body obese and type 2 diabetic volunteers using hyperinsulinemic, euglycemic clamp under saline control conditions and during an intravenous infusion of niacin. The hyperinsulinemic-euglycemic clamp is a method used to measure insulin sensitivity. Plasma insulin concentration is acutely raised and maintained at \~40-80 μU/ml (microunits per milliliter) by continuous insulin infusion. During the clamp, the plasma glucose concentration was held constant at normal blood sugar level. The glucose infusion rate over the last hour of the insulin infusion is the net effect of insulin on whole-body glucose metabolism. This rate serves as a measure of tissue insulin sensitivity. The hyperinsulinemic-euglycemic clamp assesses how sensitive your tissues are to insulin.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

12 participants

Primary outcome timeframe

18 hours

Results posted on

2025-01-17

Participant Flow

Participant milestones

Participant milestones
Measure	Niacin Then Saline Participants received intravenous Niacin overnight on day one and then intravenous saline overnight on the second study day Niacin: Intravenous infusion, a titrated dose starting from 0.6 mg/min to a maximum of 2.8 mg/min (likely needed dose = 1.4 mg/min) Saline: Intravenous infusion of 0.9% Sodium chloride (NaCl)
Niacin Infusion Intervention STARTED	12
Niacin Infusion Intervention COMPLETED	12
Niacin Infusion Intervention NOT COMPLETED	0
Saline Infustion Intervention STARTED	12
Saline Infustion Intervention COMPLETED	11
Saline Infustion Intervention NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Niacin Then Saline Participants received intravenous Niacin overnight on day one and then intravenous saline overnight on the second study day Niacin: Intravenous infusion, a titrated dose starting from 0.6 mg/min to a maximum of 2.8 mg/min (likely needed dose = 1.4 mg/min) Saline: Intravenous infusion of 0.9% Sodium chloride (NaCl)
Saline Infustion Intervention Withdrawal by Subject	1

Baseline Characteristics

Effects of Niacin on Intramyocellular Fatty Acid Trafficking in Upper Body Obesity and Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Niacin Then Saline n=12 Participants Participants received intravenous Niacin overnight on day one and then intravenous saline overnight on the second study day Niacin: Intravenous infusion, a titrated dose starting from 0.6 mg/min to a maximum of 2.8 mg/min (likely needed dose = 1.4 mg/min) Saline: Intravenous infusion of 0.9% Sodium chloride (NaCl)
Age, Continuous	38 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 hours

Outcome measures

Outcome measures
Measure	Niacin n=11 Participants Participants who received intravenous Niacin overnight on day one Niacin: Intravenous infusion, a titrated dose starting from 0.6 mg/min to a maximum of 2.8 mg/min (likely needed dose = 1.4 mg/min)	Saline n=11 Participants Participants who received intravenous saline overnight on the second study day Saline: Intravenous infusion of 0.9% Sodium chloride (NaCl)
Glucose Infusion Rate	532 microunits per milliliter Standard Deviation 214	557 microunits per milliliter Standard Deviation 256

Adverse Events

Niacin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Niacin n=12 participants at risk Participants who received intravenous Niacin overnight on day one Niacin: Intravenous infusion, a titrated dose starting from 0.6 mg/min to a maximum of 2.8 mg/min (likely needed dose = 1.4 mg/min)	Saline n=11 participants at risk Participants who received intravenous saline overnight on the second study day Saline: Intravenous infusion of 0.9% Sodium chloride (NaCl)
Musculoskeletal and connective tissue disorders muscle biopsy discomfort or drainage	8.3% 1/12 • Number of events 1 • Adverse Events were collected from baseline, first intervention of Niacin, second intervention of Saline to end of study, approximately eight weeks	18.2% 2/11 • Number of events 2 • Adverse Events were collected from baseline, first intervention of Niacin, second intervention of Saline to end of study, approximately eight weeks

Additional Information

Michael D. Jensen, M.D.

Mayo Clinic

Phone: 507-255-6515

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place