NCT02931344

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). This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

2.2 years

First QC Date

September 23, 2016

Last Update Submit

April 19, 2018

Conditions

OsteoarthrtisObesity

Keywords

OsteoarthrtisObesityLiraglutide 3 mgLiraglutideBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Change in collagen II degradation fragment α-C2M

    Blood sampling

    Week -8 to 0

Secondary Outcomes (5)

  • Change in collagen II degradation fragment β-C2M

    Week -8 to 0

  • Change in non-coding RNA type snoRNAs U38 and U48

    Week -8 to 0

  • Change in miRNA-454

    Week -8 to 0

  • Change in miRNA let-7e

    Week -8 to 0

  • Change in Nesfatin-1

    Week -8 to 0

Study Arms (1)

Intensive dietary intervention

EXPERIMENTAL

Supervised dietary weight loss program lasting 8 weeks

Dietary Supplement: Dietary Supplement: Dietary Supplement: Intensive dietary intervention

Interventions

Dietary Supplement: Dietary Supplement: Intensive dietary interventionDIETARY_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

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Same as parent trial (NCT02905864)

You may not qualify if:

  • Same as parent trial (NCT02905864)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Parker Institute

Frederiksberg, Capital Region, 2000, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 23, 2016

First Posted

October 13, 2016

Study Start

November 1, 2016

Primary Completion

January 1, 2019

Study Completion

June 1, 2019

Last Updated

April 23, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)