Trial Outcomes & Findings for Composition & Function of Sarcoplasmic Reticulum in Persons With the Metabolic Syndrome (NCT NCT02122666)
NCT ID: NCT02122666
Last Updated: 2024-10-26
Results Overview
We will take a muscle tissue sample from the subject's thigh (vastus lateralis) to quantify phosphatidylcholine to phosphatidylethanolamine ratio of the sarcoplasmic reticulum.
Recruitment status
COMPLETED
Target enrollment
27 participants
Primary outcome timeframe
Study Visit Week 4
Results posted on
2024-10-26
Participant Flow
Participant milestones
| Measure |
Metabolic Syndrome
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy: A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
|
Control
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy: A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
15
|
|
Overall Study
COMPLETED
|
12
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Composition & Function of Sarcoplasmic Reticulum in Persons With the Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
Metabolic Syndrome
n=12 Participants
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy: A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
|
Control
n=15 Participants
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy: A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 16.4 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Visit Week 4Population: Samples not included were lost during tissue processing. Metabolic syndrome (n=10); Control (n=13)
We will take a muscle tissue sample from the subject's thigh (vastus lateralis) to quantify phosphatidylcholine to phosphatidylethanolamine ratio of the sarcoplasmic reticulum.
Outcome measures
| Measure |
Metabolic Syndrome
n=10 Participants
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy: A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
|
Control
n=13 Participants
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy: A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
|
|---|---|---|
|
Sarcoplasmic Reticulum Composition
|
2.0 PC:PE ratio
Standard Error 0.2
|
2.2 PC:PE ratio
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Study visit week 4Population: Oral glucose tolerance tests were performed on 15 controls and 11 metabolic syndrome participants. The insulin data was lost for one metabolic syndrome participant.
The homeostatic model assessment for insulin resistance (HOMA-IR) is a calculated value using fasting glucose and insulin levels. It provides a measure of insulin resistance. HOMA-IR values between 0.5 and 1.4 are considered normal and values \>2.9 indicate insulin resistance. The Matsuda Index reflects insulin sensitivity. It is calculated from glucose and insulin levels drawn fasting and during an OGTT. Matsuda Index values of 2.5 or higher are normal and indicate lack of insulin resistance or normal insulin sensitivity. Results of these measures are displayed graphically in the published paper.
Outcome measures
| Measure |
Metabolic Syndrome
n=11 Participants
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy: A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
|
Control
n=15 Participants
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy: A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
|
|---|---|---|
|
Insulin Sensitivity
|
2.5 Matsuda Index
Standard Deviation 1.9
|
5.6 Matsuda Index
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Study Visit week 4Population: All study participants received DEXAs and data were reported.
We will perform a Duel Energy X-ray absorptiometry (DEXA) scan to approximate lean and fat body mass of study subjects.
Outcome measures
| Measure |
Metabolic Syndrome
n=12 Participants
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy: A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
|
Control
n=15 Participants
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy: A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
|
|---|---|---|
|
Lean and Fat Body Mass
|
43.7 Total body fat (%)
Standard Deviation 5.0
|
30.6 Total body fat (%)
Standard Deviation 7.5
|
Adverse Events
Metabolic Syndrome
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Samantha Adamson, MD, PhD
Washington University School of Medicine
Phone: 314-362-3500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place