Metabolic Complications Following Achilles Tendon Rupture - A Cohort Study

NCT02531750 | Completed DMC

• 1 other identifier: ATR_ORTHOMED
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Metabolism; Bone metabolism; Glucose Metabolism; Lipid metabolism; Low grade inflamation

Outcome Measures

Primary Outcomes (4)

• Glucose metabolism

  Insulin sensitivity as measured by MinModel-OGTT

  Metabolic derangement: 0 to 8 weeks

• Lipid metabolism

  Lipid oxidation as measured by MinModel-NEFA

  Metabolic derangement: 0 to 8 weeks

• Bone metabolism

  BMD changes in total hip

  Metabolic derangement: 0 to 8 weeks

• Atherosclerotic markers

  Changes in low density lipoprotein particles and in particle size

  Metabolic derangement: 0 to 8 weeks

Secondary Outcomes (11)

• Glucose metabolism

  Metabolic derangement: 8 weeks; Metabolic restoration 52 weeks

• Glucose metabolism

  Metabolic derangement: 8 weeks; Metabolic restoration 52 weeks

• Glucose metabolism

  Metabolic derangement: 8 weeks; Metabolic restoration 52 weeks

• Glucose metabolism

  Metabolic derangement: 8 weeks; Metabolic restoration 52 weeks

• Lipid metabolism

  Metabolic derangement: 8 weeks; Metabolic restoration 52 weeks

Study Arms (1)

Achilles tendon rupture

Patients with acute Achilles tendon rupture.

Other: Immobilization due to an Achilles tendon rupture

Interventions

Immobilization due to an Achilles tendon rupture OTHER

Achilles tendon rupture

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fifty non-diabetic individuals of age 18 to 70 years who should undergo non-operative treatment of acute Achilles tendon rupture and who are included to the randomized clinical trial: Non-operative Treatment of Acute Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization, ClinicalTrials.gov Identifier: NCT02015364 at the department of orthopaedics, Hvidovre Hospital are recruited as cases for this study.

You may qualify if:

• Individuals of age 18 to 70 years
• Rupture of Achilles tendon happened within 5 days.
• The patient must be expected to be able to attend rehabilitation and post-examinations.
• The patient must be able to speak and understand Danish.
• The patient must be able to give informed consent.

You may not qualify if:

• Former rupture of one or both Achilles tendon(s)
• Previous surgery on the Achilles tendon
• Fluoroquinolone treatment within the last 6 months
• Tendinosis treated with corticosteroids (tablets or injections) within the last 6 months.
• The patient has been diagnosed with arterial insufficiency in the legs.
• Terminal illness or severe medical illness: ASA score higher than or equal to 3.
• The space between the rupture and the calcaneus is less than 1cm.
• BMI \>/= 35 kg/m2
• Known diabetes mellitus or HbA1c \>/= 48 mol/mol
• Clinical significant anaemia, 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
• Re-rupture of the Achilles tendon between week 8 and 52

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blod and urine samples

Study Officials

• Kristoffer W Barfod, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: August 24, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

DK (1)