Trial Outcomes & Findings for Mechanisms of Insulin Resistance in Humans (NCT NCT00330967)

Results Overview

IRS-1 expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blot bands, normalized to a housekeeping protein, GAPDH, in control and treated groups.

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

4 h

Results posted on

2015-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Systemic Intralipid infusion subjects 20% Intralipid: lipid infusion	Group 2 Femoral arterial Intralipid infusion subjects 20% Intralipid: lipid infusion
Overall Study STARTED	0	25
Overall Study COMPLETED	0	11
Overall Study NOT COMPLETED	0	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Systemic Intralipid infusion subjects 20% Intralipid: lipid infusion	Group 2 Femoral arterial Intralipid infusion subjects 20% Intralipid: lipid infusion
Overall Study Withdrawal by Subject	0	5
Overall Study Physician Decision	0	9

Baseline Characteristics

Mechanisms of Insulin Resistance in Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 Systemic Intralipid infusion subjects 20% Intralipid: lipid infusion	Group 2 n=25 Participants Femoral Intralipid infusion subjects 20% Intralipid: lipid infusion	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	25 participants n=7 Participants	25 participants n=5 Participants
Age, Categorical >=65 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Continuous	—	47.65 years STANDARD_DEVIATION 11.43 • n=7 Participants	47.65 years STANDARD_DEVIATION 11.43 • n=5 Participants
Gender Female	—	4 participants n=7 Participants	4 participants n=5 Participants
Gender Male	—	21 participants n=7 Participants	21 participants n=5 Participants
Region of Enrollment United States	—	25 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 h

IRS-1 expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blot bands, normalized to a housekeeping protein, GAPDH, in control and treated groups.

Outcome measures

Outcome measures
Measure	Group 2 n=2 Participants Femoral Intralipid infusion subjects 20% Intralipid: lipid infusion
Insulin Signaling With Lipid Infusion IRS-1 Basal	0.4334 ratio Standard Deviation 0.2199
Insulin Signaling With Lipid Infusion IRS-1 Basal Lipid	0.7276 ratio Standard Deviation 0.0173
Insulin Signaling With Lipid Infusion IRS-1 Insulin	0.5264 ratio Standard Deviation 0.3810
Insulin Signaling With Lipid Infusion IRS-1 Insulin Lipid	0.3534 ratio Standard Deviation 0.1391

PRIMARY outcome

Timeframe: 4 h

Phosphorylation of p38 MAPK in response to femoral lipid and insulin infusions. phospho-p38 MAPK expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.

Outcome measures

Outcome measures
Measure	Group 2 n=2 Participants Femoral Intralipid infusion subjects 20% Intralipid: lipid infusion
Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions Phos-p38 MAPK Basal	0.000394 ratio Standard Deviation 0.000164
Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions Phos-p38 MAPK Basal Lipid	0.001271 ratio Standard Deviation 0.001013
Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions Phos-p38 MAPK Insulin	0.000337 ratio Standard Deviation 0.000140
Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions Phos-p38 MAPK Insulin Lipid	0.000270 ratio Standard Deviation 0.000049

PRIMARY outcome

Timeframe: 4 h

p38 MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.

Outcome measures

Outcome measures
Measure	Group 2 n=2 Participants Femoral Intralipid infusion subjects 20% Intralipid: lipid infusion
p38 MAPK Expression With Femoral Lipid and Insulin Infusions p38 MAPK Basal	0.000455 ratio Standard Deviation 0.0000088
p38 MAPK Expression With Femoral Lipid and Insulin Infusions p38 MAPK Basal Lipid	0.001291 ratio Standard Deviation 0.0008
p38 MAPK Expression With Femoral Lipid and Insulin Infusions p38 MAPK Insulin	0.000502 ratio Standard Deviation 0.000337
p38 MAPK Expression With Femoral Lipid and Insulin Infusions p38 MAPK Insulin Lipid	0.000377 ratio Standard Deviation 0.0000903

PRIMARY outcome

Timeframe: 4 h

Phosphorylation of ERK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.

Outcome measures

Outcome measures
Measure	Group 2 n=2 Participants Femoral Intralipid infusion subjects 20% Intralipid: lipid infusion
Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions Phos-ERK MAPK Basal	0.000091 ratio Standard Deviation 0.0000378
Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions Phos-ERK MAPK Basal Lipid	0.000108 ratio Standard Deviation 0.0000366
Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions Phos-ERK MAPK Insulin	0.000096 ratio Standard Deviation 0.0000103
Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions Phos-ERK MAPK Insulin Lipid	0.000092 ratio Standard Deviation 0.0000070

PRIMARY outcome

Timeframe: 4 h

ERK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.

Outcome measures

Outcome measures
Measure	Group 2 n=2 Participants Femoral Intralipid infusion subjects 20% Intralipid: lipid infusion
ERK MAPK Expression With Femoral Lipid and Insulin Infusions ERK MAPK Basal	0.000103 ratio Standard Deviation 0.0000722
ERK MAPK Expression With Femoral Lipid and Insulin Infusions ERK MAPK Basal Lipid	0.000158 ratio Standard Deviation 0.0000826
ERK MAPK Expression With Femoral Lipid and Insulin Infusions ERK MAPK Insulin	0.000124 ratio Standard Deviation 0.0000237
ERK MAPK Expression With Femoral Lipid and Insulin Infusions ERK MAPK Insulin Lipid	0.000114 ratio Standard Deviation 0.0000017

PRIMARY outcome

Timeframe: 4 h

Phosphorylation of JNK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.

Outcome measures

Outcome measures
Measure	Group 2 n=2 Participants Femoral Intralipid infusion subjects 20% Intralipid: lipid infusion
Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions Phos-JNK MAPK Basal	0.00401 ratio Standard Deviation 0.002967
Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions Phos-JNK MAPK Basal Lipid	0.005888 ratio Standard Deviation 0.004952
Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions Phos-JNK MAPK Insulin	0.003756 ratio Standard Deviation 0.002537
Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions Phos-JNK MAPK Insulin Lipid	0.00224 ratio Standard Deviation 0.001161

PRIMARY outcome

Timeframe: 4 h

JNK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.

Outcome measures

Outcome measures
Measure	Group 2 n=2 Participants Femoral Intralipid infusion subjects 20% Intralipid: lipid infusion
JNK MAPK Expression With Femoral Lipid and Insulin Infusions JNK MAPK Basal	0.001364 ratio Standard Deviation 0.00594
JNK MAPK Expression With Femoral Lipid and Insulin Infusions JNK MAPK Basal Lipid	0.002996 ratio Standard Deviation 0.002837
JNK MAPK Expression With Femoral Lipid and Insulin Infusions JNK MAPK Insulin	0.002151 ratio Standard Deviation 0.002032
JNK MAPK Expression With Femoral Lipid and Insulin Infusions JNK MAPK Insulin Lipid	0.001783 ratio Standard Deviation 0.001883

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 Systemic Intralipid infusion group 20% Intralipid: lipid infusion	Group 2 n=25 participants at risk Femoral Intralipid infusion group 20% Intralipid: lipid infusion
Surgical and medical procedures Edema	— 0/0	4.0% 1/25 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Charles Oh

Phoenix VA Health Care System

Phone: 602-277-5551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place