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

UMIN ID: UMIN000055418

Registered date:04/09/2024

Basic Information

• Recruitment status: Recruiting
• 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

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.
• 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
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: The present study (FU study) has no specific exclusion criteria.

Related Information

• Primary Sponsor: Chiba University Graduate Schoo
• Source(s) of Monetary Support: Suzuki Manpei foundation