OsteoarthritisCIMT-LOSEIT-INCT02954627
Ultrasound Assessment of the Carotid Intimal Medial Thickness in Obese Subjects; Weight Loss
An observational study of Osteoarthritis and Obesity, run by Henrik Gudbergsen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Osteoarthritis, Obesity
- What is being tested?
- Dietary Supplement: Intensive dietary intervention
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis
Who may be able to join
- 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
Who cannot join
- 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)
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Assessment of the Carotid Intimal Medial Thickness in Obese Subjects Following a Significant Weight Loss
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
- Osteoarthritis, Obesity
- Being tested
- Dietary Supplement: Intensive dietary intervention
- Keywords
- Osteoarthritis, Obesity, Liraglutide 3 mg, Liraglutide, Ultrasound
- Medical subject headings
- Osteoarthritis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive dietary intervention | Supervised dietary weight loss program lasting 8 weeks Receives: Dietary Supplement: Dietary Supplement: Intensive dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean posterior wall common carotid intima-media thickness in mm
Change will be assessed by grey-scale ultrasound of the posterior wall of the common carotids (one position)
Measured: Week -8 to 0
Change in the mean posterior wall common carotid intima-media thickness in mm
Change will be assessed by grey-scale ultrasound of the posterior wall of the common carotids (one position)
Measured: Week -8 to 52
Secondary outcomes (2)
Change in the maximum posterior wall common carotid intima-media thickness in mm
Change will be assessed by grey-scale ultrasound of the posterior wall of the common carotids (one position)
Measured: Week -8 to 0
Change in the maximum posterior wall common carotid intima-media thickness in mm
Change will be assessed by grey-scale ultrasound of the posterior wall of the common carotids (one position)
Measured: Week -8 to 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrik Gudbergsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrik Gudbergsen, Parker Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954627
- Sponsor's protocol ID
- 137.09
- Acronym
- CIMT-LOSEIT-I
- Status last verified
- Mar 2019
- First submitted
- 28 Oct 2016
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of the Carotid Intimal Medial Thickness in Obese Subjects Following a Significant Weight Loss
- ClinicalTrials.gov ID
- NCT02954627
- Acronym / sponsor ID
- CIMT-LOSEIT-I / 137.09
- Conditions
- Osteoarthritis, Obesity
- Keywords
- Osteoarthritis, Obesity, Liraglutide 3 mg, Liraglutide, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Henrik GudbergsenUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Feb 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive dietary intervention | – | Dietary Supplement: Dietary Supplement: Intensive dietary interventionSupervised dietary weight loss program lasting 8 weeks |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement: Intensive dietary interventionParticipants 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. | Dietary supplement | Intensive dietary intervention |
Primary outcome
Change in the mean posterior wall common carotid intima-media thickness in mm
Time frame: Week -8 to 0
Change will be assessed by grey-scale ultrasound of the posterior wall of the common carotids (one position)
Change in the mean posterior wall common carotid intima-media thickness in mm
Time frame: Week -8 to 52
Change will be assessed by grey-scale ultrasound of the posterior wall of the common carotids (one position)
2 secondary outcomes
Change in the maximum posterior wall common carotid intima-media thickness in mm
Time frame: Week -8 to 0
Change in the maximum posterior wall common carotid intima-media thickness in mm
Time frame: Week -8 to 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Obesity, run by Henrik Gudbergsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the mean posterior wall common carotid intima-media thickness in mm (time frame: Week -8 to 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.