Trial Outcomes & Findings for Metabolomic Analysis of Hepatic Insulin Resistance (NCT NCT01833403)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Baseline

Results posted on

2017-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Hyperinsulinemic-euglycemic Clamp hyperinsulinemic-euglycemic clamp Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery \-------------------------------------------------------------------------------- Glucose
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metabolomic Analysis of Hepatic Insulin Resistance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hyperinsulinemic-euglycemic Clamp n=4 Participants hyperinsulinemic-euglycemic clamp Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery \-------------------------------------------------------------------------------- Glucose
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	40 years STANDARD_DEVIATION 4 • n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	4 participants n=99 Participants
insulin sensitivity	3.55 HOMA IR STANDARD_DEVIATION 2.9 • n=99 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Hyperinsulinemic-euglycemic Clamp n=4 Participants hyperinsulinemic-euglycemic clamp Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery \-------------------------------------------------------------------------------- Glucose
Insulin Sensitivity	8 m value Standard Deviation 2

PRIMARY outcome

Timeframe: 1 month

Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 150-180 minute interval of the clamp

Outcome measures

Outcome measures
Measure	Hyperinsulinemic-euglycemic Clamp n=4 Participants hyperinsulinemic-euglycemic clamp Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery \-------------------------------------------------------------------------------- Glucose
Insulin Sensitivity	8.5 mg glucose /kg FFM/min Standard Error 2

Adverse Events

Hyperinsulinemic-euglycemic Clamp

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

Lisa Chow MD

University of Minnesota

Phone: 612-625-8934

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place