Cardiometabolic effect of weight loss in metabolically healthy obese subjects
- Conditions
- ObesityNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN88315555
- Lead Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
- Brief Summary
2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28682864 results 2018 Other publications in https://pubmed.ncbi.nlm.nih.gov/29434314/ Substudy results (added 18/08/2023) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31093012/ (added 18/08/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 279
1. Aged 35-55 years
2. Metabolically healthy obese (MHO)*
3. BMI between 30-45 kg/m2
*A participant is considered to have MHO status when meeting =1 of these four metabolic syndrome criteria: fasting plasma glucose =100 mg/dL, blood pressure =135/85 mmHg (or use of blood pressure-lowering agents), HDL-cholesterol =50 mg/dL, and triglycerides =150 mg/dL (or use of lipid-lowering therapies).
1. Diabetes or impaired glucose tolerance
2. Hypertension
3. Pregnancy or planning to become pregnant during the study
4. Cardiovascular disease
5. Severe systemic disease (advanced organ failure, dementia, cancer)
6. Immobilized individuals
7. Alcohol or drug abuse
8. Severe psychiatric illness
9. Patients who self-initiated a program of physical activity or started a diet in the past three months
10. Weight loss =5 kg in the last 6 months of unknown cause
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Type 2 diabetes and/or prediabetes incidence is determined by measuring:<br>1. Fasting plasma glucose levels at baseline, 3, 6, 12, 18 and 24 months<br>2. Oral glucose tolerance testat baseline, 12 and 24 months<br>3. Glycated hemoglobin (HbA1c) at baseline, 3, 6, 12, 18 and 24 months
- Secondary Outcome Measures
Name Time Method