Trial Outcomes & Findings for Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow up (NCT NCT01412554)

Results Overview

The primary outcome is insulin sensitivity measured as the glucose disposal rate (GDR) (mg/kg/min), calculated from the average glucose infusion rate during the last 20 minutes of a 120 minutes hyperinsulinaemic isoglycaemic glucose clamp.

Recruitment status

COMPLETED

Target enrollment

103 participants

Primary outcome timeframe

One-day visit and the analyses will be done when all patients are examined in the period 2012-2013

Results posted on

2019-10-10

Participant Flow

During 1991-96 men from the military enlistments were examined at Center of Cardiovascular and Renal Research, Division of Medicine, Oslo University Hospital, Ullevål, using hyperinsulinaemic isoglycaemic glucose clamp technique to assess insulin sensitivity. They were re-invited to participate in the presented study during 2012-13.

103 consented to participation.

Participant milestones

Participant milestones
Measure	Longitudinal Insulin Sensitivity The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
Overall Study STARTED	103
Overall Study COMPLETED	103
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow up

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Longitudinal Insulin Sensitivity n=103 Participants The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
Age, Continuous	40 years STANDARD_DEVIATION 4 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	103 Participants n=93 Participants

PRIMARY outcome

Timeframe: One-day visit and the analyses will be done when all patients are examined in the period 2012-2013

The primary outcome is insulin sensitivity measured as the glucose disposal rate (GDR) (mg/kg/min), calculated from the average glucose infusion rate during the last 20 minutes of a 120 minutes hyperinsulinaemic isoglycaemic glucose clamp.

Outcome measures

Outcome measures
Measure	Longitudinal Insulin Sensitivity n=103 Participants The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
Exploring Insulin Sensitivity After 10-20 Years of Follow-up	7 mg/kg/min Standard Deviation 2

PRIMARY outcome

Timeframe: 20 years

The primary outcome is insulin sensitivity measured as the glucose disposal rate (GDR) (mg/kg/min), calculated from the average glucose infusion rate during the last 20 minutes of a 120 minutes hyperinsulinaemic isoglycaemic glucose clamp.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One-day visit and analyses will be done during 2012-2013

A mental arithmetic stress test will be announced and performed immediately after the glucose clamp, to assess the effects of increased adrenaline and noradrenaline when hepatic glucose production is suppressed by hyperinsulinaemia. Blood pressure, heart rate and catecholamine blood-levels are measured at pre-defined intervals.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One-day visit, final analyses 2012-2013

Transthoracic echocardiography will be performed using a VIVID E9 (or VIVID 7) echocardiographic scanner (GE Vingmed, Horten) with 1,7-MHz probe in second harmonic mode and optimal gain and contrast.Left ventricular (LV) internal dimension, intraventricular septal thickness and LV posterior wall thickness will be measured as well as epicardial adipose tissue. We will also evaluate biplane Simpson ejection fraction and valvular incompetence

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One-day visit. Final analyses of the whole cohort during 2012-2013

Ultrasound quantification of abdominal adipose tissue

Outcome measures

Outcome data not reported

Adverse Events

Longitudinal Insulin Sensitivity

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

MD PhD Tonje Amb Aksnes

Oslo University Hospital Ullevål, Norway

Phone: +22119101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place