Clinical trial NCT04622982: A Multidisciplinary Intervention for Weight Loss
Official title: Efficacy and Safety of a Long-term Multidisciplinary Weight Loss Intervention in Patients With Obesity: an Open Label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label study
Primary purpose: TREATMENT

Brief summary: This is an open label study in which obese participants were treated with a restrictive hypo-caloric diet under hospitalization for a maximum period of 3 months in a metabolic rehabilitation unit. A multidisciplinary approach was used (combination of diet, physical exercise and psychotherapy)


Eligibility criteria: Inclusion Criteria:

* age \>= 18
* BMI \>= 30
* one or more comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others)

Exclusion Criteria:

* active cancer
* severe cognitive or functional impairments
* severe behavioral disorders
* known kidney failure (previous glomerular filtration rate \<30 ml/min)
* known liver failure (Child B or C)

Primary outcomes:
measure: Body Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: GlycaemIa
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
measure: Homa IR
timeFrame: 12 weeks
measure: Total cholesterol
timeFrame: 12 weeks
measure: LDL cholesterol
timeFrame: 12 weeks
measure: HDL cholesterol
timeFrame: 12 weeks
measure: Triglycerides
timeFrame: 12 weeks
measure: AST (Aspartate Aminotransferase)
timeFrame: 12 weeks
measure: ALT (alanine aminotransferase)
timeFrame: 12 weeks
measure: GGT (gamma-glutamyl transpeptidase)
timeFrame: 12 weeks
measure: Total bilirubin
timeFrame: 12 weeks
measure: Basal metabolic rate
timeFrame: 12 weeks
Other outcomes:
measure: Body composition - Body Fat Mass
timeFrame: 12 weeks
measure: Body composition - Body Fat free mass
timeFrame: 12 weeks
measure: Body composition - Visceral Fat mass
timeFrame: 12 weeks
measure: Body Circumferences - arm
timeFrame: 12 weeks
measure: Body Circumferences - calf
timeFrame: 12 weeks
measure: Body Circumferences - waist
timeFrame: 12 weeks
measure: Body Circumferences - hips
timeFrame: 12 weeks
measure: Iron
timeFrame: 12 weeks
measure: Other biochemical parameters - vit D
timeFrame: 12 weeks
measure: Other biochemical parameters - vit B12
timeFrame: 12 weeks
measure: Other biochemical parameters - Folates
timeFrame: 12 weeks
measure: Other biochemical parameters - transferrin
timeFrame: 12 weeks
measure: Other biochemical parameters - Homocystein
timeFrame: 12 weeks
measure: Other biochemical parameters - albumin
timeFrame: 12 weeks
measure: Other biochemical parameters - prealbumin
timeFrame: 12 weeks
measure: Other biochemical parameters - enzymes - lipase
timeFrame: 12 weeks
measure: Other biochemical parameters - enzymes - amylase
timeFrame: 12 weeks
measure: Other biochemical parameters - thyroid hormones - FT3
timeFrame: 12 weeks
measure: Other biochemical parameters - thyroid hormones - FT4
timeFrame: 12 weeks
measure: Other biochemical parameters - thyroid hormones - TSH
timeFrame: 12 weeks
measure: Other biochemical parameters - inflammatory markers - CRP
timeFrame: 12 weeks
measure: Other biochemical parameters - inflammatory markers - ESR
timeFrame: 12 weeks
measure: Other biochemical parameters - creatinin
timeFrame: 12 weeks
measure: Uric acid
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Azienda di Servizi alla Persona di Pavia
name: Mariangela Rondanelli, MD, PhD
role: STUDY_DIRECTOR
References: