Trial Outcomes & Findings for Hyperglycemia and Mitochondrial Function in The Endothelium of Humans (NCT NCT02682342)

Last Updated: 2025-01-10

Results Overview

The investigators visualize the mitochondrial network complexity in these cells using our previously reported and validated immunofluorescence method using cytochrome c antibodies to tag the mitochondria. Network fragmentation (total number of fragments/ total fluorescent pixels\*100) will be quantified by network fragmentation count calculated with ImageJ (NIH, Bethesda) using a validated protocol.

Recruitment status

COMPLETED

Target enrollment

35 participants

Primary outcome timeframe

Measured at 0,1, and 2 hours after administration

Results posted on

2025-01-10

Participant Flow

Recruitment in southeastern Wisconsin by flyers and electronic advertisements from November 2016 through December 2019

Four subjects were disqualified during screening for cardiovascular risk factors (3 due to elevated total cholesterol and one due to hypertension). One additional subject withdrew consent during screening. One additional subject qualified for the study but never scheduled a study visit. These subjects are not in the 35 subject considered enrolled in the study

Participant milestones

Participant milestones
Measure	Healthy Subjects Healthy subjects meeting inclusion criteria will be administered a 75 g glucose solution one time (orally). Subjects will be ages 21-70 years with no evidence of diabetes, hypertension, metabolic syndrome, or high cholesterol at the time of screening. Potential subjects with a history of atherosclerotic disease, chronic renal insufficiency (plasma creatinine \> 1.5 men, \> 1.5 women), liver enzymes \> 2.5x normal, pregnant at the time of screening will be excluded 75 g glucose solution: This is the same as the standard oral glucose challenge dose and route given clinically
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hyperglycemia and Mitochondrial Function in The Endothelium of Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Subjects n=35 Participants Healthy subjects meeting inclusion criteria will be administered a 75 g glucose solution one time (orally). Subjects will be ages 21-70 years with no evidence of diabetes, hypertension, metabolic syndrome, or high cholesterol at the time of screening. Potential subjects with a history of atherosclerotic disease, chronic renal insufficiency (plasma creatinine \> 1.5 men, \> 1.5 women), liver enzymes \> 2.5x normal, pregnant at the time of screening will be excluded 75 g glucose solution: This is the same as the standard oral glucose challenge dose and route given clinically
Age, Continuous	38 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 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	2 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	4 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants
Body Mass Index	26.6 kg/m2 STANDARD_DEVIATION 4.3 • n=5 Participants
Systolic Blood Pressure	118 mmHg STANDARD_DEVIATION 10 • n=5 Participants
Diastolic Blood Pressure	72 mmHg STANDARD_DEVIATION 7 • n=5 Participants
Hemoglobin A1C	5.4 % STANDARD_DEVIATION 0.4 • n=5 Participants
Heart Rate	70 bpm STANDARD_DEVIATION 11 • n=5 Participants
Total Cholesterol	183 mg/dl STANDARD_DEVIATION 35 • n=5 Participants
HDL Cholesterol	63 mg/dl STANDARD_DEVIATION 21 • n=5 Participants
LDL Cholesterol	106 mg/dl STANDARD_DEVIATION 26 • n=5 Participants
Triglycerides	71 mg/dl STANDARD_DEVIATION 28 • n=5 Participants
Fasting Glucose	93 mg/dl STANDARD_DEVIATION 9 • n=5 Participants
Serum Creatinine	0.88 mg/dl STANDARD_DEVIATION 0.18 • n=5 Participants
Waist Circumference	91 cm STANDARD_DEVIATION 13 • n=5 Participants

PRIMARY outcome

Timeframe: Measured at 0,1, and 2 hours after administration

Population: The samples quality when we went back to look at the cells was too poor to obtain valid and reproducible measurements so the outcome was not used.

Outcome measures

Outcome data not reported

Adverse Events

Healthy Subjects

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Healthy Subjects n=35 participants at risk Healthy subjects meeting inclusion criteria will be administered a 75 g glucose solution one time (orally). Subjects will be ages 21-70 years with no evidence of diabetes, hypertension, metabolic syndrome, or high cholesterol at the time of screening. Potential subjects with a history of atherosclerotic disease, chronic renal insufficiency (plasma creatinine \> 1.5 men, \> 1.5 women), liver enzymes \> 2.5x normal, pregnant at the time of screening will be excluded 75 g glucose solution: This is the same as the standard oral glucose challenge dose and route given clinically
Metabolism and nutrition disorders Asymptomatic hypoglycemia	11.4% 4/35 • Adverse event data were collected over the patient enrollment period of the study (from 2016 through 2023). Each subject was only followed for adverse events for 2 hours following the completion of study protocol Asymptomatic hypoglycemia

Additional Information

Michael E. Widlansky, MD

Medical College of Wisconsin

Phone: 414-955-6708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place