Trials / Completed
CompletedNCT02954627
Ultrasound Assessment of the Carotid Intimal Medial Thickness in Obese Subjects; Weight Loss
Ultrasound Assessment of the Carotid Intimal Medial Thickness in Obese Subjects Following a Significant Weight Loss
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Henrik Gudbergsen · Academic / Other
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2019-02-01
- Completion
- 2019-03-01
- First posted
- 2016-11-03
- Last updated
- 2019-03-25
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT02954627. Inclusion in this directory is not an endorsement.