Metabolic Complications Following Knee Injury in Young and Middle Aged Patients
OrthoMetKnee
1 other identifier
observational
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedNovember 10, 2015
November 1, 2015
10 months
March 13, 2015
November 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in insulin sensitivity
Glucose metabolic: -insulin sensitivity as measured by MinModel-OGTT
Baseline to week 6
Secondary Outcomes (5)
Change in glucose metabolism
Baseline to week 6 and to week 16
Lipid metabolism
Baseline to week 6 and to week 16
Bone Metabolism
Baseline to week 6 and to week 16
Atherosclerotic markers
Baseline to week 6 and to week 16
Change in insulin sensitivity
week 6 and to week 16
Study Arms (2)
Case subjects
Physical active non-diabetic individuals of age 18 to 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. OGTT, blood- and urine sampling and DXA scans will be performed 3 times throughout the study period.
Control group
Non-diabetic individuals matched for age, gender and physical activity are recruited as control subjects to establish a reference level likely to image the cases before they experienced their knee injury. Blood- and urine sampling, OGTT and DXA scans will be carried out 1-3 times for each control subject. No lifestyle intervention is implemented.
Interventions
Eligibility Criteria
Sixteen physical active non-diabetic individuals of age 18 to 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. Ten non-diabetic individuals matched for age, gender and physical activity are recruited as control subjects. The pre-surgical physical activity level is expected to be lower than their habitual physical activity, however more than that which would be expected from individuals with a sedentary life-style. At least 6 of the control subjects will be examined another two times, that is, after 6 weeks and after 16 weeks for the purpose of time controls.
You may qualify if:
- Individuals of age 18 to 50 years
- Physically active \>/= 1.5 hours/week up till baseline examination
- Physically active at least 2.5 hours/week before knee injury.
- The participants should undergo one of the following orthopaedic surgical procedures; Medial patella-femoral ligament (MPFL) surgery, Anterior Crusiate Ligament (ACL) and/or Posterior Crusiate Ligament (PCL) surgery, Knee Cartilage Injury surgery
- Informed written consent
You may not qualify if:
- BMI \>/= 30 kg/m2
- Not physically active before surgical procedure as measured by questionnaire
- Known diabetes mellitus or HbA1c \>/= 48 mol/mol
- Clinical significant anemia, liver or kidney disease as judged by the sponsor or principal investigator.
- Thyroid function abnormality (TSH \< 0.1 or TSH \> 10)
- Calcium metabolic derangement, Ca++ \< 1.1 or Ca++ \> 1.40
- Known osteoporosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haugaard, Steen Bendix, M.D., DMSclead
- Hölmich, Per, M.D.collaborator
Study Sites (1)
Amager University Hospital
Copenhagen, 2300, Denmark
Biospecimen
Blood and Urine sampling
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Per Hölmich, MD, DMSc
Amager Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2015
First Posted
October 12, 2015
Study Start
April 1, 2015
Primary Completion
February 1, 2016
Study Completion
June 1, 2016
Last Updated
November 10, 2015
Record last verified: 2015-11