obesity, health disorders including type 2 diabetes
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be included. 1) Patients who have participated in the SLIM-TARGET study. 2) Patients who have given a full explanation of their participation in this study (FU study), and who have given their free and voluntary written consent based on a full understanding of the study.
Exclusion criteria
Exclusion criteria: The present study (FU study) has no specific exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with weight loss and improvement in two or more comorbid health problems (quantifiable obesity-related diseases) at 60 months of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints Proportion of patients meeting at least two of the above (primary endpoints) at 36 and 48 months. Percentage of patients who lost weight at 36 months. Percentage of patients with a reduction in the treatment for a health problem at 48 months. Percentage of patients with a reduction in the medicinal treatment for a health problem at 60 months. Percentage of cases meeting one of the above-mentioned improvements in health problems at 36 months Percentage of cases meeting one of the above-mentioned improvements in health problems at 48 months Percentage of cases meeting one of the above-mentioned improvements in health disability at 60 months. Proportion of cases with zero disability Percentage change in body weight Reduction in visceral fat mass Percentage reduction in HbA1c Percentage change in serum lipids Percentage decrease in AST Rate of decrease in ALT Rate of decrease in gamma-GTP Percentage decrease in systolic and diastolic blood pressure Percentage decrease in Epworth Sleepiness Scale score Percentage change in willingness to treat, joint pain and dysmenorrhoea scores in the study subjects using the questionnaire Drop-out rate of study subjects in the standard and intensified treatment groups Secondary safety endpoints Frequency of adverse events. Incidence frequency of sudden death, cardiovascular events, stroke, malignancy, psychiatric disorders, musculoskeletal disorders, etc. | — |
Countries
Japan
Contacts
Chiba University Graduate School of Medicin Department of Endocrinology, Hematology and Gerontology