Ultrasound Assessment of the Adventitia, Extra-media (EMT) and Veia Jugularis Interna Thickness

NCT03208881 | Unknown DMC

• 1 other identifier: 137.10
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a substudy to a randomised 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 an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which 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 substudy aims to investigate any changes in the thickness of Adventitia, Extra-media (EMT) and veia jugularis assessed by ultrasound in relation to an initial 8-week weight loss intervention. Change will be assessed by grey-scale ultrasound, the area measured will be from the anterior wall of arteria carotis interna to the jugular vein including the wall of the vein, subsequent the thickness of the artery will be subtracted to measure the thickness of the of Adventitia, Extra-media (EMT) and veia jugularis interna compelx.

Conditions

Osteoarthritis, Obesity

Keywords

Osteoarthritis, Obesity, Liraglutide, Ultrasound

Outcome Measures

Primary Outcomes (1)

• Change in the mean thickness of adventitia, extra-media thickness (EMT), and vena jugularis interna assessed in mm

  This sub study aims to investigate any changes in the thickness of adventitia, EMT, and vena jugularis assessed by ultrasound in relation to a weight loss intervention. Change will be assessed by grey-scale ultrasound, the area measured will be from the anterior wall of arteria carotis interna to the jugular vein including the wall of the vein, subsequent the thickness of the artery will be subtracted to measure the thickness of the of adventitia, EMT, and vena jugularis interna.

  Week -8 to 0

Secondary Outcomes (3)

• Change in the maximal thickness of adventitia, extra-media thickness (EMT), and vena jugularis interna assessed in mm

  Week -8 to 0

• Long-term change in the mean thickness of adventitia, extra-media thickness (EMT), and vena jugularis interna assessed in mm

  Week 0 to 52

• Long-term change in the maximal thickness of adventitia, extra-media thickness (EMT), and vena jugularis interna assessed in mm

  Week 0 to 52

Study Arms (1)

Intensive dietary intervention

Supervised dietary weight loss program lasting 8 weeks

Dietary Supplement: Dietary Supplement: Intensive dietary intervention

Interventions

Dietary Supplement: Intensive dietary intervention DIETARY_SUPPLEMENT

Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.

Intensive dietary intervention

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henrik Gudbergsen: lead

Study Sites (1)

Osteoarthritis Clinic

Frederiksberg, Capital Region, 2000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis; Obesity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior researcher, principal investigator, MD, PhD, MPA

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: July 6, 2017
• Study Start: July 15, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

DK (1)