Glucose Metabolism DisordersOrthoMetKneeNCT02573662
Metabolic Complications Following Knee Injury in Young and Middle Aged Patients
An observational study of Glucose Metabolism Disorders and Lipid Metabolism Disorders, run by Haugaard, Steen Bendix, M.D., DMSc at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders, Lipid Metabolism Disorders, Sedentary Lifestyle
- What is being tested?
- Blood and Urine sampling, DXA scan and OGTT
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
- Inclusion/exclusion criteria for control subjects are similar except from surgical procedure
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Amager University Hospital
Copenhagen, 2300
Steen B Haugaard, MD, DMSc, +45 53555066, sbhau@dadlnet.dk
About this study
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.
Read more
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.
Read the detailed description
Hypothesis Implementation of a sedentary lifestyle with almost no physical activity in otherwise physical active individuals undergoing knee orthopaedic surgical procedures will during 6 weeks (4 to 8 weeks)
- derange insulin sensitivity and glucose effectiveness
- decrease disposition index
- imply hyper-secretion of incretin hormones and glucagon
- compensatory decrease in insulin clearance
- decrease lipid oxidation
- increase visceral adipose tissue
- increase number of low density lipoprotein particles and a decrease the particle size
- increase immune and low grade inflammatory response as measured in plasma and urine
- induce bone loss in hip as measured by bone mineral density (BMD)
- increase bone resorption and decrease bone formation as measured by selected bone turnover markers.
The proposed negative changes in bone, lipid and glucose metabolism are thought to reverse at least partly so, during active physical rehabilitation during week 6 through week 16.
Statistics Ten days of bed rest in 13 healthy young individuals showed a 20% (P<0.05) significant decrease in insulin sensitivity and a 50% (P<0.05) reduction in lipid oxidation. Thirty-one days of bed rest in 8 healthy women was significantly associated with bone loss in total hip (2.07%, P<0.001).
As the present study does not imply strict bed rest but exhibit a longer sedentary period of following up as the above studies and include a larger number of participants we are very likely to exhibit a power > 80% at significance level
Ethical issues The study is approved by the local scientific ethical committee and the Danish Data Protection Agency. The study adheres to the Danish Act on Processing of Personal Data and, Danish Act on Health and the Helsinki II convention of clinical trials. The study will be announced at the clinicaltrials.gov homepage. All participants are informed about the purpose of the study, all ethical issues and a written consent is obtained before participation.
Personal data from patient medical files will be accessed by principal investigator to gather information concerning the knee injuries in order to identify and characterize the knee injury for each subject. Personal data concerning demographic relations such as gender and age will be accessed as well to ensure the case subjects meet the inclusion criteria and for statistically use. To make assessments on study participation, the principal investigator will also gain access to relevant data from the patient s medical files concerning illnesses or conditions the case subject might report. The X-ray radiation from 1 DXA scan equals 1 day of background radiation in Denmark. Thus 3 DXA scans throughout the study period are equal to 3 days of background radiation. This amount of radiation is 30-fold less than that of a single standard CT-scan of abdomen. In other words the dose of radiation is so low that a calculation of risk is not possible.
The amount of blood drawn during the approximately 16 weeks of participation in the study is less than 500 ml, which is the standard amount of blood drawn at a single donation of blood from a blood donor. The use of intravenous cannula can cause irritation or infection of vein or insertion site. All procedures will be performed as described in SOP.
- Being tested
- Blood and Urine sampling, DXA scan, OGTT
- Keywords
- Metabolic complications, Type 2 diabetes, Sedentary lifestyle, Low grade inflammation, Lipid metabolism, Glucose metabolism, Bone metabolism, Physical inactivity
- Medical subject headings
- Glucose Metabolism Disorders, Lipid Metabolism Disorders, Sedentary Behavior, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and Urine samplingBiological
Blood and Urine Sampling
DXA scanRadiation
Scan of Lumbar columna and neck of femur/hip Scan of visceral/subcutaneous fatty tissue
OGTTBiological
Oral Glucose Tolerance Test for Minimal Model analysis for insulin sensitivity and Lipid oxidation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Blood and Urine sampling; Radiation: DXA scan; Biological: OGTT | |
| 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. Receives: Biological: Blood and Urine sampling; Radiation: DXA scan; Biological: OGTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity
Glucose metabolic: -insulin sensitivity as measured by MinModel-OGTT
Measured: Baseline to week 6
Secondary outcomes (5)
Change in glucose metabolism
- Change in beta-cell responsiveness compared to insulin sensitivity (disposition index)
- Change in glucose effectiveness
- Change in insulin clearance
- Change in visceral adipose tissue
- Change in incretin secretion compared to insulin resistance and insulin secretion
Measured: Baseline to week 6 and to week 16
Lipid metabolism
- Change ind lipid oxidation as measured by MinModel-NEFA
- Change in lipolysis
- Change in rates of which NEFA leaves plasma pool
Measured: Baseline to week 6 and to week 16
Bone Metabolism
- BMD changes in total hip; changes in total BMD
- change in lumbar BMD
- changes in BTM of bone resorption (CTX) and formation (P1NP)
Measured: Baseline to week 6 and to week 16
Atherosclerotic markers
- change in low and high density lipoprotein particles and in particle size
- changes in TNFa, IL6, hsCRP, suPAR and orosomucoid
Measured: Baseline to week 6 and to week 16
Change in insulin sensitivity
Glucose metabolic: -insulin sensitivity as measured by MinModel-OGTT
Measured: week 6 and to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haugaard, Steen Bendix, M.D., DMSc
- Collaborators
- Hölmich, Per, M.D.
- Responsible party
- Sponsor
- Investigators
- Per Hölmich, MD, DMSc, Principal investigator, Amager Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573662
- Sponsor's protocol ID
- AH-ORTHOMET-01
- Acronym
- OrthoMetKnee
- Status last verified
- Nov 2015
- First submitted
- 13 Mar 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Complications Following Knee Injury in Young and Middle Aged Patients
- ClinicalTrials.gov ID
- NCT02573662
- Acronym / sponsor ID
- OrthoMetKnee / AH-ORTHOMET-01
- Keywords
- Metabolic complications, Type 2 diabetes, Sedentary lifestyle, Low grade inflammation, Lipid metabolism, Glucose metabolism, Bone metabolism, Physical inactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Haugaard, Steen Bendix, M.D., DMSc
- Collaborators
- Hölmich, Per, M.D.
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothesis Implementation of a sedentary lifestyle with almost no physical activity in otherwise physical active individuals undergoing knee orthopaedic surgical procedures will during 6 weeks (4 to 8 weeks)
- derange insulin sensitivity and glucose effectiveness
- decrease disposition index
- imply hyper-secretion of incretin hormones and glucagon
- compensatory decrease in insulin clearance
- decrease lipid oxidation
- increase visceral adipose tissue
- increase number of low density lipoprotein particles and a decrease the particle size
- increase immune and low grade inflammatory response as measured in plasma and urine
- induce bone loss in hip as measured by bone mineral density (BMD)
- increase bone resorption and decrease bone formation as measured by selected bone turnover markers.
The proposed negative changes in bone, lipid and glucose metabolism are thought to reverse at least partly so, during active physical rehabilitation during week 6 through week 16.
Statistics Ten days of bed rest in 13 healthy young individuals showed a 20% (P<0.05) significant decrease in insulin sensitivity and a 50% (P<0.05) reduction in lipid oxidation. Thirty-one days of bed rest in 8 healthy women was significantly associated with bone loss in total hip (2.07%, P<0.001).
As the present study does not imply strict bed rest but exhibit a longer sedentary period of following up as the above studies and include a larger number of participants we are very likely to exhibit a power > 80% at significance level
Ethical issues The study is approved by the local scientific ethical committee and the Danish Data Protection Agency. The study adheres to the Danish Act on Processing of Personal Data and, Danish Act on Health and the Helsinki II convention of clinical trials. The study will be announced at the clinicaltrials.gov homepage. All participants are informed about the purpose of the study, all ethical issues and a written consent is obtained before participation.
Personal data from patient medical files will be accessed by principal investigator to gather information concerning the knee injuries in order to identify and characterize the knee injury for each subject. Personal data concerning demographic relations such as gender and age will be accessed as well to ensure the case subjects meet the inclusion criteria and for statistically use. To make assessments on study participation, the principal investigator will also gain access to relevant data from the patient s medical files concerning illnesses or conditions the case subject might report. The X-ray radiation from 1 DXA scan equals 1 day of background radiation in Denmark. Thus 3 DXA scans throughout the study period are equal to 3 days of background radiation. This amount of radiation is 30-fold less than that of a single standard CT-scan of abdomen. In other words the dose of radiation is so low that a calculation of risk is not possible.
The amount of blood drawn during the approximately 16 weeks of participation in the study is less than 500 ml, which is the standard amount of blood drawn at a single donation of blood from a blood donor. The use of intravenous cannula can cause irritation or infection of vein or insertion site. All procedures will be performed as described in SOP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case subjects | – | Biological: Blood and Urine sampling, Radiation: DXA scan, Biological: OGTTPhysical 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 | – | Biological: Blood and Urine sampling, Radiation: DXA scan, Biological: OGTTNon-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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and Urine samplingBlood and Urine Sampling | Biological | Case subjects, Control group |
| DXA scanScan of Lumbar columna and neck of femur/hip Scan of visceral/subcutaneous fatty tissue | Radiation | Case subjects, Control group |
| OGTTOral Glucose Tolerance Test for Minimal Model analysis for insulin sensitivity and Lipid oxidation | Biological | Case subjects, Control group |
Primary outcome
Change in insulin sensitivity
Time frame: Baseline to week 6
Glucose metabolic: -insulin sensitivity as measured by MinModel-OGTT
5 secondary outcomes
Change in glucose metabolism
Time frame: Baseline to week 6 and to week 16
Lipid metabolism
Time frame: Baseline to week 6 and to week 16
Bone Metabolism
Time frame: Baseline to week 6 and to week 16
Atherosclerotic markers
Time frame: Baseline to week 6 and to week 16
Change in insulin sensitivity
Time frame: week 6 and to week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Hölmich, MD, DMSc principal investigator
Amager Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Metabolism Disorders and Lipid Metabolism Disorders, run by Haugaard, Steen Bendix, M.D., DMSc at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steen B Haugaard, MD, DMSc (+45 53555066, sbhau@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin sensitivity (time frame: Baseline to week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.