Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
151 participants
INTERVENTIONAL
2016-02-01
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All participants
Obese subjects with BMI \>= 30 and with one or more of metabolic comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others).
Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy)
Body weight reduction was induced by a low-energy mixed diet (55 % carbohydrates, 30 % lipids and 15 % proteins) providing 600 kcal less than individually estimated energy requirements based on the measured REE. The energy content and macronutrient composition of the diets adhered to the nutritional recommendations of the American Diabetes Association.
Patients were administered vitamin D supplement only if they presented a value of 25-hydroxyvitamin D (25OHD) \<30 ng/ml in blood tests at the beginning.
Patients were following an individualized physical activity plan within the hospital and were aided by a psychodynamic approach therapist.
Interventions
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Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy)
Body weight reduction was induced by a low-energy mixed diet (55 % carbohydrates, 30 % lipids and 15 % proteins) providing 600 kcal less than individually estimated energy requirements based on the measured REE. The energy content and macronutrient composition of the diets adhered to the nutritional recommendations of the American Diabetes Association.
Patients were administered vitamin D supplement only if they presented a value of 25-hydroxyvitamin D (25OHD) \<30 ng/ml in blood tests at the beginning.
Patients were following an individualized physical activity plan within the hospital and were aided by a psychodynamic approach therapist.
Eligibility Criteria
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Inclusion Criteria
* BMI \>= 30
* one or more comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others)
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Azienda di Servizi alla Persona di Pavia
OTHER
Responsible Party
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Principal Investigators
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Mariangela Rondanelli, MD, PhD
Role: STUDY_DIRECTOR
Azienda di Servizi alla Persona di Pavia
Other Identifiers
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1206/151217
Identifier Type: -
Identifier Source: org_study_id