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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2016 |
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Main ID: |
NCT02559479 |
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Date of registration:
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22/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes
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Scientific title:
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A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02559479 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Fernando Civeira, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Unidad Clínica y de Investigación en Lípidos y Arteriosclerosis; Hospital U. Miguel Servet; IIS Aragón |
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Name:
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Fernando Civeira, MD, PhD |
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Address:
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Telephone:
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+34 976765500 |
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Email:
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civeira@unizar.es |
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Affiliation:
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Name:
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Rocio Mateo-Gallego, RD, PhD |
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Address:
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Telephone:
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+34 976765500 |
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Email:
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rmateo.iacs@aragon.es |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age: 18-70 years old.
- Body mass index between 27.5 - 40.
- Steady weight (± 4 kg) in the last 2 months.
- Glycated hemoglobin between 6 - 7%.
Exclusion Criteria:
- Anti-diabetic drugs (oral or subcutaneous) in the last 2 months.
- Lipid-lowering drugs in the last 2 months.
- Gouty arthritis in the last 2 years or uric acid > 735 mg/dl.
- Presence of uncontrolled endocrinological pathology (including hypothyroidism).
- Hepatic chronic disease (glomerular filtration rate < 45 ml/min).
- Renal, inflammatory or tumoral diseases.
- Drugs which could interfere in glucose or lipid metabolism such as androgens,
corticosteroids (except for those with topic administration) and estrogen replacement
therapy.
- Intake of functional foods with plant sterols in the past 6 weeks.
- High alcohol intake (> 30 g per day).
- Any serious disease which involves less than 1 year life expectancy or, in
investigators judgment, limit the follow-up of an homogeneous diet throughout the
study.
- Pregnancy or intention of pregnancy during the study.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Weight Loss
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Carbohydrates
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Diet, Reducing
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Protein
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Diabetes
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Obesity
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Intervention(s)
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Behavioral: Weight loss interventional study with a low-calorie 18%-protein diet
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Behavioral: Weight loss interventional study with a low-calorie 35%-protein diet
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Primary Outcome(s)
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Change in glycated hemoglobin.
[Time Frame: After 3 and 6 months of intervention.]
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Change in insulin resistance (HOMA index).
[Time Frame: After 3 and 6 months of intervention.]
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Change in glucose.
[Time Frame: After 3 and 6 months of intervention.]
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Secondary Outcome(s)
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Change in body composition.
[Time Frame: After 3 and 6 months of intervention.]
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Change in waist circumference.
[Time Frame: After 3 and 6 months of intervention.]
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Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, non HDL cholesterol, triglycerides and apolipoproteins).
[Time Frame: After 3 and 6 months of intervention.]
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Change in body weight.
[Time Frame: After 3 and 6 months of intervention.]
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Secondary ID(s)
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CEICA;PI/15/0183
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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