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OpenTrials
Completed

NCT Number: NCT04622982

A Multidisciplinary Intervention for Weight Loss

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)

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy)

Other

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.

Primary outcomes

  1. Body Weight

    Time frame: 12 weeks

    Change in body Weight

Secondary outcomes

  1. GlycaemIa

    Time frame: 12 weeks

    Change in glycaemia

  2. Insulin

    Time frame: 12 weeks

    Change in insulin blood levels

  3. Homa IR

    Time frame: 12 weeks

    Change in HOMA-IR

  4. Total cholesterol

    Time frame: 12 weeks

    Change in blood total cholesterol

  5. LDL cholesterol

    Time frame: 12 weeks

    Change in LDL cholesterol

  6. HDL cholesterol

    Time frame: 12 weeks

    Change in HDL cholesterol

  7. Triglycerides

    Time frame: 12 weeks

    Change in triglycerides

  8. AST (Aspartate Aminotransferase)

    Time frame: 12 weeks

    Change in blood of Aspartate Aminotransferase (AST)

  9. ALT (alanine aminotransferase)

    Time frame: 12 weeks

    Change in blood of alanine aminotransferase (ALT)

  10. GGT (gamma-glutamyl transpeptidase)

    Time frame: 12 weeks

    Change in blood of gamma-glutamyl transpeptidase (GGT)

  11. Total bilirubin

    Time frame: 12 weeks

    Change in blood total bilirubin

  12. Basal metabolic rate

    Time frame: 12 weeks

    Change in basal metabolic rate

Other outcomes

  1. Body composition - Body Fat Mass

    Time frame: 12 weeks

    Change in Body Fat

  2. Body composition - Body Fat free mass

    Time frame: 12 weeks

    change in Body Fat free mass

  3. Body composition - Visceral Fat mass

    Time frame: 12 weeks

    change in Visceral Fat mass

  4. Body Circumferences - arm

    Time frame: 12 weeks

    change in circumferences (arm)

  5. Body Circumferences - calf

    Time frame: 12 weeks

    change in circumferences (calf)

  6. Body Circumferences - waist

    Time frame: 12 weeks

    change in circumferences ( waist)

  7. Body Circumferences - hips

    Time frame: 12 weeks

    change in circumferences (hips)

  8. Iron

    Time frame: 12 weeks

    Change in blood Iron concentration

  9. Other biochemical parameters - vit D

    Time frame: 12 weeks

    Change in blood vitamin D

  10. Other biochemical parameters - vit B12

    Time frame: 12 weeks

    Change in blood vitamin B12

  11. Other biochemical parameters - Folates

    Time frame: 12 weeks

    Change in blood Folates

  12. Other biochemical parameters - transferrin

    Time frame: 12 weeks

    Change in transferrin

  13. Other biochemical parameters - Homocystein

    Time frame: 12 weeks

    Change in Homocystein

  14. Other biochemical parameters - albumin

    Time frame: 12 weeks

    Change in blood proteins (albumin)

  15. Other biochemical parameters - prealbumin

    Time frame: 12 weeks

    Change in blood proteins (prealbumin)

  16. Other biochemical parameters - enzymes - lipase

    Time frame: 12 weeks

    Change in blood enzymes (lipase)

  17. Other biochemical parameters - enzymes - amylase

    Time frame: 12 weeks

    Change in blood enzymes (amylase)

  18. Other biochemical parameters - thyroid hormones - FT3

    Time frame: 12 weeks

    Change in FT3

  19. Other biochemical parameters - thyroid hormones - FT4

    Time frame: 12 weeks

    Change in FT4

  20. Other biochemical parameters - thyroid hormones - TSH

    Time frame: 12 weeks

    Change in TSH

  21. Other biochemical parameters - inflammatory markers - CRP

    Time frame: 12 weeks

    Change in C-reactive protein

  22. Other biochemical parameters - inflammatory markers - ESR

    Time frame: 12 weeks

    Change in Erythrocyte Sedimentation Rate

  23. Other biochemical parameters - creatinin

    Time frame: 12 weeks

    Change in blood creatinin

  24. Uric acid

    Time frame: 12 weeks

    Change in uric acid blood concentration

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

Efficacy and Safety of a Long-term Multidisciplinary Weight Loss Intervention in Patients With Obesity: an Open Label Study

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Nov 10, 2020
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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