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Ultrasound Assessment of the Carotid Intimal Medial Thickness in Obese Subjects; Weight Loss

NCT02954627 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2019-03-25

No results posted yet for this study

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 carotid intima media thickness (CIMT) assessed by ultrasound in relation to an initial 8-week weight loss intervention.

Conditions

Interventions

DIETARY_SUPPLEMENT

Dietary Supplement: Intensive dietary intervention

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.

Sponsors & Collaborators

  • Henrik Gudbergsen

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-02-28
Completion
2019-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT02954627 on ClinicalTrials.gov