Status:
COMPLETED
Effect of Weight Loss on Hepcidin Levels and Iron Status in Subjects with Obesity.
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Obesity
Iron Deficiency Anemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Obesity and iron deficiency are the nutritional disorders with the highest prevalence worldwide. Different mechanisms have been proposed to explain iron deficiency secondary to obesity. Among the most...
Detailed Description
The study will consist of two phases: Phase 1, which will be cross-sectional, and Phase 2, which will involve a randomized controlled clinical trial. Phase 1: Cross-Sectional Study A cross-sectional ...
Eligibility Criteria
Inclusion
- Phase 1
- Signing of the informed consent form
- Both sexes
- Adults over 18 years of age
- BMI of 18.5 and under 40 kg/m2
- Phase 2
- Both sexes
- Adults older than 18 years
- People with obesity (BMI of 30 to 40 kg/m2) and serum iron \< 50 micrograms/dL.
- Total cholesterol less than 240 mg/dL (with the diet plan 20% decrease).
Exclusion
- Any type of diabetes.
- Patients with renal disease diagnosed by a physician.
- Patients with acquired diseases that secondarily produce obesity and diabetes.
- Patients who have suffered a cardiovascular event.
- Weight loss \> 3 kg in the last 3 months.
- Patients with catabolic diseases such as cancer and acquired immunodeficiency syndrome.
- Pregnancy.
- Treatment with any drug treatment:
- Treatment with antihypertensive drugs (loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).
- Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or insulin and antidiabetics.
- Treatment with statins, fibrates or other drugs to control dyslipidemia.
- Use of steroid drugs, chemotherapy, immunosuppressants or radiotherapy.
- Anorectics or drugs that accelerate weight loss.
- Any drug or medication that activates intestinal motility (cisapride, dimethicone, domperidone, metoclopramide, trimebutine).
- Laxatives or antispasmodics 4 weeks prior to the study h) Antibiotic treatment 2 months prior to the study.
- Patients who have suffered a blood loss of more than 500 ml or recent gastrointestinal tract perforation.
- Patients with a smoking index greater than 21.
- Consumption of large amounts of alcohol (14 drinks for women or 21 drinks for men in a normal week).
- Consumption of any recreational psychoactive substance.
- Treatment with any medication that influences inflammation or iron metabolism (proton pump inhibitors, antacids, bisphosphonates, bile acid or calcium sequestrants).
- Patients who are vegetarians
- Allergy or intolerance to any food mentioned in the proposed pantry such as egg, dairy, fish, tuna, chicken, beans, lima beans and/or lentils.
- Unwillingness to consume any of the foods listed in the proposed pantry.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06104800
Start Date
January 8 2024
End Date
January 24 2025
Last Update
January 27 2025
Active Locations (1)
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1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
México, Mexico