NCT01412554

Brief Summary

The purpose of this study is to identify risk factors for insulin resistance and to investigate the influence of insulin sensitivity on development of cardiovascular risk markers like blood pressure, heart rate, body build (weight, BMI, waist-hip ratio, skinfold thickness), reduced insulin sensitivity, diabetes mellitus, dyslipidaemia, and sympathoadrenal activity or manifest cardiovascular disease among young men during 10-20 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

October 10, 2019

Completed
Last Updated

October 10, 2019

Status Verified

September 1, 2019

Enrollment Period

2.6 years

First QC Date

July 22, 2011

Results QC Date

September 20, 2017

Last Update Submit

September 20, 2019

Conditions

Diabetes MellitusHypertensionIschemic Heart DiseaseStroke

Keywords

Insulin resistanceDiabetes mellitusAdipositas

Outcome Measures

Primary Outcomes (2)

  • Exploring Insulin Sensitivity After 10-20 Years of Follow-up

    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.

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

  • Exploring Insulin Sensitivity After 10-20 Years of Follow-up

    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.

    20 years

Secondary Outcomes (3)

  • Sympathoadrenal Activity During Rest and Stress Tests

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

  • Echocardiography

    One-day visit, final analyses 2012-2013

  • Ultrasound Abdomen

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

Study Arms (1)

Longitudinal Insulin Sensitivity

The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.

Eligibility Criteria

Age30 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

103 men previously examined with hyperinsulinemic glucose clamp, measuring insulin sensitivity, at Center of Cardiovascular and Renal Research, Division of Medicine, Oslo University Hospital, Ullevål.

You may qualify if:

  • Completed hyperinsulinemic glucose clamp

You may not qualify if:

  • Missing agreement
  • No contact information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Cardiovascular and Renal Research

Oslo, 0407, Norway

Location

Related Publications (2)

  • Akra S, Aksnes TA, Flaa A, Eggesbo HB, Opstad TB, Njerve IU, Seljeflot I. Markers of remodeling in subcutaneous adipose tissue are strongly associated with overweight and insulin sensitivity in healthy non-obese men. Sci Rep. 2020 Aug 20;10(1):14055. doi: 10.1038/s41598-020-71109-4.

    PMID: 32820223DERIVED

  • Skarn SN, Eggesbo HB, Flaa A, Kjeldsen SE, Rostrup M, Brunborg C, Reims HM, Aksnes TA. Predictors of abdominal adipose tissue compartments: 18-year follow-up of young men with and without family history of diabetes. Eur J Intern Med. 2016 Apr;29:26-31. doi: 10.1016/j.ejim.2015.11.027. Epub 2015 Dec 23.

    PMID: 26712453DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, white cells, urine, fat tissue cells

MeSH Terms

Conditions

Diabetes MellitusHypertensionMyocardial IschemiaStrokeInsulin ResistanceObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesHeart DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHyperinsulinismOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Results limited to the study group

Results Point of Contact

Title
MD PhD Tonje Amb Aksnes
Organization
Oslo University Hospital Ullevål, Norway
tonjeaksnes@hotmail.com
+22119101

Study Officials

  • Sverre E Kjeldsen, PhD

    Oslo Univeristy Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 22, 2011

First Posted

August 9, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

October 10, 2019

Results First Posted

October 10, 2019

Record last verified: 2019-09

Locations

NO(1)