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Changes in Skin Autoflouresence Following Weight Loss and Maintenance Using Liraglutide in Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Liraglutide 3 mg (Saxenda)
Liraglutide 3 mg placebo
Sponsored by
Parker Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Same as parent trial (NCT02905864)

Inclusion Criteria:

  • Informed consent obtained
  • Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3)
  • Age ≥ 18 years and < 75 years
  • Body mass index (BMI) ≥ 27 kg/m2
  • Stable body weight during the previous 3 months (< 5 kg self-reported weight change)
  • Motivated for weight loss

Exclusion Criteria:

  • On-going participation, or participation within the last 3 months, in an organised weight loss programme (or within the last 3 months)
  • Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
  • Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine
  • Type 1 diabetes
  • Type 2 diabetes treated with glucose-lowering drugs other than metformin
  • Alloplasty in target knee joint (see section 6.3)
  • End stage disease in target knee joint (Kellgren-Lawrence grade 4)
  • Immuno-inflammatory disease
  • Chronic wide-spread pain
  • Pregnancy or insufficient anti-conception therapy for female fertile patients
  • Breast-feeding
  • Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x above upper normal range (UNR)
  • Surgery scheduled for the trial duration period, except for minor surgical procedures
  • Surgical procedures such as arthroscopy or injections into a knee within 3 months prior to enrolment
  • Previous surgical treatment for obesity (excluding liposuction >1 year before trial entry)
  • Thyroid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
  • Obesity secondary to endocrinologic or eating disorders or to treatment with medicinal products that may cause weight gain
  • Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
  • Inflammatory bowel disease
  • Congestive heart failure, New York Heart Association (NYHA) class III-IV
  • Diabetic gastroparesis
  • History of or current diagnosis of pancreatitis (acute and/or chronic) or pancreatic cancer
  • History of cancer with the exception of in-situ malignancies of the skin or cervix uteri
  • History of major depressive disorder, a PHQ-9 (Patient Health Questionnaire-9) score of more than 15, or a history of other severe psychiatric disorders or diagnosis of an eating disorder
  • Subjects with a lifetime history of a suicide attempt or history of any suicidal behaviour within the past month before entry into the trial
  • Inability to speak Danish fluently
  • A mental state impeding compliance with the program
  • Use of opioids or similar strong analgesics
  • Allergic reactions to the active ingredients of Saxenda, such as hypotension, palpitations, dyspnoea and oedema

Sites / Locations

  • Department of Rheumatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liraglutide 3 mg

Liraglutide 3 mg placebo

Arm Description

Subjects will be up titrated to liraglutide 3 mg QD and stay on that dose for the remainder of the 52-week drug intervention period.

Subjects will be up titrated to liraglutide 3 mg placebo QD and stay on that dose for the remainder of the 52-week drug intervention period.

Outcomes

Primary Outcome Measures

Change in advanced glycation end products in the skin
advanced glycation end products levels will be measured on the skin of the volar side of the forearm using skin auto fluorescence

Secondary Outcome Measures

Change in advanced glycation end products in the skin
advanced glycation end products levels will be measured on the skin of the volar side of the forearm using skin auto fluorescence.

Full Information

First Posted
September 20, 2016
Last Updated
March 21, 2019
Sponsor
Parker Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02910570
Brief Title
Changes in Skin Autoflouresence Following Weight Loss and Maintenance Using Liraglutide in Knee Osteoarthritis
Official Title
The Association Between Weight Loss With Subsequent Maintenance Using Liraglutide and Changes in Skin Autoflouresence in Overweight or Obese Patients With Knee Osteoarthritis - a Substudy to "Effect of Liraglutide on Body Weight and Pain in Overweight or Obese Patients With Knee Osteoarthritis: A Randomised, Double Blind, Placebo-controlled, Parallel Group, Single-centre Trial" (NCT02905864)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parker Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is sub-study to a randomised, double blind, placebo-controlled, parallel group, and single-centre trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial patients will be subjected to a run-in diet intervention phase (week -8 to 0) including a low-calorie diet and dietetic counselling. At week 0 patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. This sub-study of the parent trial only involves an additional assessment of skin auto fluorescence (AGE concentration) in the preallocation phase and in the main trial phase, i.e. from enrollment (defined as signature of informed consent) to treatment allocation (visits -Tx and T0 in the parent trial visit schedule) and from allocation to end of trial (visits T0 and T15 in the parent trial visit schedule).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide 3 mg
Arm Type
Experimental
Arm Description
Subjects will be up titrated to liraglutide 3 mg QD and stay on that dose for the remainder of the 52-week drug intervention period.
Arm Title
Liraglutide 3 mg placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be up titrated to liraglutide 3 mg placebo QD and stay on that dose for the remainder of the 52-week drug intervention period.
Intervention Type
Drug
Intervention Name(s)
Liraglutide 3 mg (Saxenda)
Intervention Description
Dose escalation scheme: Initial dosage of 0.6 mg per day, escalated bi-weekly by 0.6 mg to 3 mg per day over a total of 8 weeks
Intervention Type
Drug
Intervention Name(s)
Liraglutide 3 mg placebo
Intervention Description
Dose escalation scheme: Initial dosage of a 0.6 mg drug equivalent volume per day, escalated bi-weekly by an 0.6 mg drug equivalent volume per day to a 3 mg drug equivalent volume per day over a total of 8 weeks.
Primary Outcome Measure Information:
Title
Change in advanced glycation end products in the skin
Description
advanced glycation end products levels will be measured on the skin of the volar side of the forearm using skin auto fluorescence
Time Frame
week 0 to 52
Secondary Outcome Measure Information:
Title
Change in advanced glycation end products in the skin
Description
advanced glycation end products levels will be measured on the skin of the volar side of the forearm using skin auto fluorescence.
Time Frame
week -8 to 0 (pre-randomisation weight loss intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Same as parent trial (NCT02905864) Inclusion Criteria: Informed consent obtained Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3) Age ≥ 18 years and < 75 years Body mass index (BMI) ≥ 27 kg/m2 Stable body weight during the previous 3 months (< 5 kg self-reported weight change) Motivated for weight loss Exclusion Criteria: On-going participation, or participation within the last 3 months, in an organised weight loss programme (or within the last 3 months) Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine Type 1 diabetes Type 2 diabetes treated with glucose-lowering drugs other than metformin Alloplasty in target knee joint (see section 6.3) End stage disease in target knee joint (Kellgren-Lawrence grade 4) Immuno-inflammatory disease Chronic wide-spread pain Pregnancy or insufficient anti-conception therapy for female fertile patients Breast-feeding Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x above upper normal range (UNR) Surgery scheduled for the trial duration period, except for minor surgical procedures Surgical procedures such as arthroscopy or injections into a knee within 3 months prior to enrolment Previous surgical treatment for obesity (excluding liposuction >1 year before trial entry) Thyroid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L Obesity secondary to endocrinologic or eating disorders or to treatment with medicinal products that may cause weight gain Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 Inflammatory bowel disease Congestive heart failure, New York Heart Association (NYHA) class III-IV Diabetic gastroparesis History of or current diagnosis of pancreatitis (acute and/or chronic) or pancreatic cancer History of cancer with the exception of in-situ malignancies of the skin or cervix uteri History of major depressive disorder, a PHQ-9 (Patient Health Questionnaire-9) score of more than 15, or a history of other severe psychiatric disorders or diagnosis of an eating disorder Subjects with a lifetime history of a suicide attempt or history of any suicidal behaviour within the past month before entry into the trial Inability to speak Danish fluently A mental state impeding compliance with the program Use of opioids or similar strong analgesics Allergic reactions to the active ingredients of Saxenda, such as hypotension, palpitations, dyspnoea and oedema
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik R Gudbergsen, MD, PhD
Organizational Affiliation
The Parker Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology
City
Frederiksberg
State/Province
Capital Region
ZIP/Postal Code
2000
Country
Denmark

12. IPD Sharing Statement

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Changes in Skin Autoflouresence Following Weight Loss and Maintenance Using Liraglutide in Knee Osteoarthritis

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