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Trial Outcomes & Findings for A Study to Evaluate the Effect of Lipid Infusion on Toll Like Receptor 4 (TLR4) Signaling (NCT NCT01740817)

NCT ID: NCT01740817

Last Updated: 2016-01-25

Results Overview

Forty eight hrs after lipid or saline infusion, muscle insulin sensitivity will be measured by insulin clamp. The results are compared to determine whether lipid infusion reduces muscle insulin sensitivity compared to saline infusion.. The M value is defined as the exogenous glucose infusion rate at steady state (i.e, when the exogenous glucose infusion rate is equal to the rate of whole body glucose disposal).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

48 hr after lipid/saline infusion

Results posted on

2016-01-25

Participant Flow

12 of 52 participants were randomized. Of those not randomized, 40 did not meet inclusion criteria.

Participant milestones

Participant milestones
Measure
Lipid Then Saline
Intralipid 20% 30 ml/h for 48 h, then saline 30 ml/h for 48 h
Saline Then Lipid
Saline infusion 30 ml/h for 48 h, then lipid 30 ml/h for 48 h
First Intervention (48 h)
STARTED
8
4
First Intervention (48 h)
COMPLETED
8
4
First Intervention (48 h)
NOT COMPLETED
0
0
Washout (4-6 Weeks)
STARTED
8
4
Washout (4-6 Weeks)
COMPLETED
8
4
Washout (4-6 Weeks)
NOT COMPLETED
0
0
Second Intervention (48 h)
STARTED
8
4
Second Intervention (48 h)
COMPLETED
8
4
Second Intervention (48 h)
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Effect of Lipid Infusion on Toll Like Receptor 4 (TLR4) Signaling

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=12 Participants
Participants who were randomized to receive either lipid or saline
Age, Continuous
39 years
STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants

PRIMARY outcome

Timeframe: 48 hr after lipid/saline infusion

Forty eight hrs after lipid or saline infusion, muscle insulin sensitivity will be measured by insulin clamp. The results are compared to determine whether lipid infusion reduces muscle insulin sensitivity compared to saline infusion.. The M value is defined as the exogenous glucose infusion rate at steady state (i.e, when the exogenous glucose infusion rate is equal to the rate of whole body glucose disposal).

Outcome measures

Outcome measures
Measure
Saline
n=12 Participants
Saline infusion at 30 ml/h for 48 h
Intralipid
n=12 Participants
liposyn infusion at 30 ml/h for 48 hrs
Muscle Insulin Sensitivity-M Value
9.9 mg/kg.min
Standard Error 0.7
8.3 mg/kg.min
Standard Error 0.7

SECONDARY outcome

Timeframe: 48 hr following lipid/saline infusion, pre-clamp

Forty eight hrs after lipid or saline infusion, muscle TLR4 mRNA levels will be measured by RT-PCR. The results are compared to determine whether lipid infusion increases muscle TLR4 mRNA expression compared to saline infusion. Saline mean was used to normalize the data for both arms.

Outcome measures

Outcome measures
Measure
Saline
n=12 Participants
Saline infusion at 30 ml/h for 48 h
Intralipid
n=12 Participants
liposyn infusion at 30 ml/h for 48 hrs
TLR4 Messenger Ribonucleic Acid (mRNA) in Muscle
1 ng TLR4 mRNA/ng Actin mRNA
Standard Error 0.15
1.6 ng TLR4 mRNA/ng Actin mRNA
Standard Error 0.2

SECONDARY outcome

Timeframe: 48 hr following lipid or saline infusion, pre-clamp

Forty eight hrs after lipid or saline infusion, muscle ERK phosphorylation will be measured by western blot. The results are compared to determine whether lipid infusion increases muscle ERK phosphorylation compared to saline infusion. Saline mean was used to normalize the data for both arms.

Outcome measures

Outcome measures
Measure
Saline
n=12 Participants
Saline infusion at 30 ml/h for 48 h
Intralipid
n=12 Participants
liposyn infusion at 30 ml/h for 48 hrs
Extracellular Signal-regulated Kinase (ERK) Phosphorylation in Muscle
1.0 densitometry value
Standard Error 0.18
1.95 densitometry value
Standard Error 0.3

Adverse Events

Saline

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intralipid

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

Dr. Nicolas Musi

University of Texas Health Science Center at San Antonio

Phone: 200-562-6152

Results disclosure agreements

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