ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound Assessment of the Carotid Intimal Medial Thickness in Obese Subjects; Weight Loss (CIMT-LOSEIT-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02954627
Recruitment Status : Active, not recruiting
First Posted : November 3, 2016
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Henrik Gudbergsen, Parker Research Institute

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


Condition or disease Intervention/treatment
Osteoarthritis Obesity Dietary Supplement: Dietary Supplement: Intensive dietary intervention

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Assessment of the Carotid Intimal Medial Thickness in Obese Subjects Following a Significant Weight Loss
Study Start Date : November 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Intensive dietary intervention
Supervised dietary weight loss program lasting 8 weeks
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.




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. Change in the maximum 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)

  2. Change in the maximum 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954627


Locations
Denmark
Osteoarthritis Clinic
Frederiksberg, Capital Region, Denmark, 2000
Sponsors and Collaborators
Henrik Gudbergsen

Responsible Party: Henrik Gudbergsen, MD, PhD, Parker Research Institute
ClinicalTrials.gov Identifier: NCT02954627     History of Changes
Other Study ID Numbers: 137.09
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Henrik Gudbergsen, Parker Research Institute:
Osteoarthritis
Obesity
Liraglutide 3 mg
Liraglutide
Ultrasound

Additional relevant MeSH terms:
Osteoarthritis
Weight Loss
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists