Metabolic Complications Following Knee Injury in Young and Middle Aged Patients

NCT02573662 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2015-11-10

No results posted yet for this study

Summary

Introduction This study evaluates the effect on glucose, lipid and bone metabolism following knee orthopedic procedures in healthy and physically active individuals. The sedentary rehabilitation period following these procedures may impact negatively on glucose, lipid and bone metabolic pathways, whereas the more physically active rehabilitation period instituted 6 weeks after surgery is hypothesized to impact positively.

Perspective This study will establish whether the well-known effects on glucose, lipid and bone metabolism of a sedentary lifestyle can be observed already following 6 weeks of physical inactivity in otherwise healthy and physically fit young and middle aged individuals. Investigators will thereby add knowledge to previous findings following strict bed-rest in healthy individuals on glucose, lipid and bone metabolism. In a clinical perspective it is important to examine the extent to which healthy individuals deteriorate in various metabolic pathways to better understand the pathophysiology behind these defects both in healthy individuals and in patients, who undergo bed rest or an equal reduction in physical activity as part of their rehabilitation.

Study design 16 physical active non-diabetic individuals of age 18 - 50 years who are undergoing knee surgical procedures at the Arthroscopic Center at Amager/Hvidovre Hospitals are recruited as cases for this case-control study.

10 non-diabetic control subjects matched for age, gender and physical activity are recruited to establish a reference level.

* The individuals will bring in morning spot urine for measurement of soluble urokinase plasminogen activating receptor (suPAR), creatinine, albumin and orosomucoid. Weight and height and waist and hip circumference will be measured.
* Oral glucose tolerance test (OGTT) with ingestion of 75 g glucose during 5 min from baseline (0 min). Plasma for glucose, insulin, C-peptide, non-esterified fatty acid (NEFA) will be drawn
* Before OGTT blood will be drawn for measurement of HbA1c, total cholesterol, LDL, HDL, triglyceride, Na, K, creatinine, hemoglobin (HgB), C-reactive protein (CRP), leukocytes, alanintransaminase (ALAT), alkaline phosphatase, Ca++, D vitamin, TSH, bone turnover markers (BTM), suPAR, interleukin 6 (IL6), TNFa, high-sensitivity C-reactive protein (hsCRP), lipid density profiling and lipid particle size.
* Dual energy X-ray absorptiometry (DXA) of hip, lumbar columna, visceral and subcutaneous fat is measured by Hologic Discovery scanner.

Conditions

  • Glucose Metabolism Disorders
  • Lipid Metabolism Disorders
  • Sedentary Lifestyle

Interventions

BIOLOGICAL

Blood and Urine sampling

Blood and Urine Sampling

RADIATION

DXA scan

Scan of Lumbar columna and neck of femur/hip Scan of visceral/subcutaneous fatty tissue

BIOLOGICAL

OGTT

Oral Glucose Tolerance Test for Minimal Model analysis for insulin sensitivity and Lipid oxidation

Sponsors & Collaborators

  • Hölmich, Per, M.D.

    collaborator INDIV
  • Haugaard, Steen Bendix, M.D., DMSc

    lead INDIV

Principal Investigators

  • Per Hölmich, MD, DMSc · Amager Hospital

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-02-29
Completion
2016-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02573662 on ClinicalTrials.gov