UMIN ID: UMIN000055418
Registered date:04/09/2024
Follow up Study of weight Loss Intervention to find effective strategy for obesity Management and the TARGET of weight loss amount for reducing health disorders
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | obesity, health disorders including type 2 diabetes |
Date of first enrollment | 2025/03/31 |
Target sample size | 294 |
Countries of recruitment | Japan |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | Percentage of patients with weight loss and improvement in two or more comorbid health problems (quantifiable obesity-related diseases) at 60 months of intervention. |
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Secondary Outcome | 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. |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | The present study (FU study) has no specific exclusion criteria. |
Related Information
Primary Sponsor | Chiba University Graduate Schoo |
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Secondary Sponsor | |
Source(s) of Monetary Support | Suzuki Manpei foundation |
Secondary ID(s) |
Contact
public contact | |
Name | Mayumi Shoji |
Address | 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan Japan 260-8677 |
Telephone | 043-222-7171 |
adaa4124@chiba-u.jp | |
Affiliation | Chiba University Graduate School of Medicin Department of Endocrinology, Hematology and Gerontology |
scientific contact | |
Name | Kotaro Yokote |
Address | 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan. Japan |
Telephone | 043-222-7171 |
willo_the_wisp_mayumi@yahoo.co.jp | |
Affiliation | Chiba University Graduate School of Medicine Department of Endocrinology, Hematology and Gerontology |