NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedobesity, health disorders including type 2 diabetes
Date of first enrollment2025/03/31
Target sample size294
Countries of recruitmentJapan
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomePercentage of patients with weight loss and improvement in two or more comorbid health problems (quantifiable obesity-related diseases) at 60 months of intervention.
Secondary OutcomeSecondary 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 minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaThe present study (FU study) has no specific exclusion criteria.

Related Information

Contact

public contact
Name Mayumi Shoji
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan Japan 260-8677
Telephone 043-222-7171
E-mail 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
E-mail willo_the_wisp_mayumi@yahoo.co.jp
Affiliation Chiba University Graduate School of Medicine Department of Endocrinology, Hematology and Gerontology