MedTrace Logo

Metabolic Complications Following Achilles Tendon Rupture - A Cohort Study

NCT02531750 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2017-08-09

No results posted yet for this study

Summary

Introduction This study will evaluate the effect on glucose, lipid and bone metabolism following conservative orthopaedic procedures in patients who suffered from acute Achilles tendon rupture. The sedentary rehabilitation period following these procedures may impact negatively upon glucose, lipid and bone metabolic pathways whereas the more physically active rehabilitation period instituted 8 weeks after the injury is hypothesized to impose positive metabolic effects.

The study is addition to the on-going clinical trial, Non-operative Treatment of Acute Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization, ClinicalTrials.gov Identifier: NCT02015364.

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 8 weeks of almost total abstain from physical activity in non-diabetic individuals, who suffered an acute Achilles tendon rupture. Thereby, we will add knowledge to the previous findings following strict bed-rest in healthy individuals on glucose and lipid metabolism and bone turnover. In a clinical perspective it is important to examine the extent to which 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 The present study includes 50 cases, who are examined early following injury (\< 2 weeks) (baseline), 8 weeks (6 - 10 weeks) after injury and 52 weeks (40 - 64 weeks) after injury, respectively.

Oral glucose tolerance test (OGTT) with ingestion of 75 g of glucose during a maximum of 3 min from baseline (0 min). Plasma for glucose, insulin, C-peptide, NEFA will be drawn.

The individual will bring in morning spot urine for measurement of suPAR, creatinine, albumin and orosomucoid.

The individual will have drawn blood for measurement of HbA1c, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, Na, K, creatinine, HgB, CRP, leukocytes, ALAT, alkaline phosphatase, Ca++, D vitamin, TSH, albumine and amylase. Also blood for BTM and plasma suPAR, IL6, TNFa and hsCRP will be drawn. Finally blood for lipid density profiling and lipid particle size will be drawn DXA of hip and lumbar spine including abdominal visceral and subcutaneous fat is done on a Hologic Discovery scanner.

Conditions

  • Achilles Tendon Rupture
  • Immobilization

Interventions

OTHER

Immobilization due to an Achilles tendon rupture

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Kristoffer W Barfod, MD · Hvidovre University Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT02531750 on ClinicalTrials.gov