Anorexia Nervosa Clinical Trial
Official title:
Comparison of the Effects of Weight Changes on Serum Adipokines in Patients Diagnosed With Anorexia Nervosa and Morbid Obesity
| NCT number | NCT04663919 |
| Other study ID # | 246164 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 1, 2014 |
| Est. completion date | January 1, 2015 |
| Verified date | December 2020 |
| Source | Istanbul University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In this study, when patients diagnosed with AN started treatment and their weight increased by 10%; On the other hand, it was aimed to compare the changes in serum adipokine levels observed in morbidly obese patients before bariatric surgery and when they lost 10% of their post-op weight with both anthropometric measurements, biochemical parameters, and values of healthy volunteers.
| Status | Completed |
| Enrollment | 55 |
| Est. completion date | January 1, 2015 |
| Est. primary completion date | April 7, 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 13 Years to 60 Years |
| Eligibility | Inclusion Criteria: - for Anorexia Nervosa group: - Have been diagnosed with anorexia nervosa - BMI <18 kg/m2 - Good general health - Volunteering to participate in the study - for Morbidly Obese group: - Who was diagnosed with morbid obesity and planned to undergo RYGB operation - BMI> 40 kg/m2 - Volunteering to participate in the study - for Healthy Volunteers: - Good general health - BMI >20 and <30 kg/m2 - Volunteering to participate in the study Exclusion Criteria: - <13 and> 60 years old - to had type 2 diabetes, hypertension, liver and kidney failure, cancer, or a chronic disease |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Istanbul University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Serum glucose change | Change in baseline glucose (mg/dl) at when decreasing by 10 percent or increasing by 10 percent from initial weight. | 3 months on average | |
| Other | Serum insulin change | Change in baseline insulin (µU/mL) at when decreasing by 10 percent or increasing by 10 percent from initial weight. | 3 months on average | |
| Other | Serum CRP change | Change in baseline CRP at when decreasing by 10 percent or increasing by 10 percent from initial weight. | 3 months on average | |
| Primary | Plasma Leptin levels changes: | Change in baseline Leptin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples. | 3 months on average | |
| Primary | Plasma Apelin levels changes | Change in baseline Apelin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples. | 3 months on average | |
| Primary | Plasma Omentin levels changes | Change in baseline Omentin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples. | 3 months on average | |
| Primary | Plasma Adiponectin levels changes | Change in baseline Adiponectin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples. | 3 months on average | |
| Primary | Plasma IL-6 levels changes | Change in baseline IL-6 levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples. | 3 months on average | |
| Secondary | Weight change | Change in baseline weight (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight. | 3 months on average | |
| Secondary | Fat mass change | Change in baseline fat mass (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight. | 3 months on average | |
| Secondary | Fat free mass changes | Change in baseline fat free mass (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight. | 3 months on average |
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