- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00858221
Association of Genes to Resistance to Weight Loss in Obese Patients
Association of Genetic Variants in Obesity Genes to Resistance to Weight Loss and Susceptibility to Metabolic Syndrome in Morbidly Obese Patients: A Single Center, Blinded, Retrospective Clinical Study
The overall goal of this study is to determine whether variations in the perilipin, and several other, genes would be a useful tool for physicians who are caring for morbidly obese patients to guide therapy.
The main hypotheses to be tested is that sequence variations (polymorphisms) in the perilipin gene and several other obesity-related genes are associated with resistance to weight loss for obese individuals on energy restricted diets, potentially playing a role in the development of obesity related complications.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The PRIMARY goal of this study is to investigate the association of perilipin gene polymorphisms, with obese subjects who are "resistant" to weight loss in a defined program.
The SECONDARY goal of this study is to investigate if additional candidate obesity genes that have previously been associated with obesity or energy metabolism show association with resistance to weight loss in subjects on an energy restricted diet. Additionally, we would like to investigate if any metabolic syndrome parameters, such as dyslipidemia or abnormal fasting glucose are associated with perilipin or variations in other obesity-related genes.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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Pennsylvania
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Danville, Pennsylvania, Forenede Stater, 17822
- Geisinger Health System
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Caucasian
- competent patients interested in Gastric Bypass Surgery
patients who are eligible for Gastric Bypass Surgery based on NIH criteria:
- Male or Female
- 21 - 70 years old, inclusive
- Body Mass Index (BMI) > 40 with 2 co-morbid conditions such as Sleep Apnea, Hypertension, or Type 2 Diabetes
- BMI > 45 with no co-morbid conditions
Exclusion Criteria:
- Patients not interested in Gastric Bypass Surgery
- Patients who do not qualify for surgery based on medical contraindications
- Patients with severe psychological contraindications
- Patients not willing to be compliant with pre-post surgical recommendations
- Patients younger than 21 years of age
- Patients older than 70 years of age
- Patients who do not qualify for surgery based on insurance constraints i.e., insurance guidelines for bypass surgery
- Patients who are pregnant
- Hispanic, Black, Asian Races
- Abnormal thyroid function
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Significant association of perilipin gene polymorphisms with obese subjects who are resistant to weight loss in a defined program.
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Significant association of other genes, known to be obesity-related, with resistance to weight loss. Also, association of primary and secondary gene SNPs with dyslipidemia.
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Karen Shaver, MS, Interleukin Genetics
- Ledende efterforsker: Christopher D. Still, MD, Geisinger Clinic
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ILI-08-107PLIN
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