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Improvement of Insulin Resistance After Bariatric Surgery
Mechanisms Underlying the Improvement of Insulin Resistance in Response to Bariatric Surgery
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Bariatric and weight loss surgery is an effective treatment for severe obesity. Bariatric surgery also decreases insulin resistance and improves diabetes. Our study enrolled individuals approved for bariatric surgery to collect data on modifiable predictors and laboratory outcomes. These data would allow us to systematically assess clinical outcomes over one year post bariatric surgery and elucidate how insulin resistance is decreased and diabetes is improved.
The type of surgery was selected by the subjects between Roux-en-Y gastric bypass or a laparoscopic adjustable gastric banding. Participation in the study involved having a small sample of tissue obtained from the abdomen and subjects were also given the option to have a biopsy performed in the thigh area during their elective surgical procedure (optional adipose and muscle tissue biopsies).
Subjects were examined prior to surgery and at 2, 3, 6 months after intervention. Anthropometric and body composition measurements were performed using the Bioelectrical Impendence Analysis (BIA) before surgery and 6 months post operatively. Morning blood was collected after overnight fasting during each visit. Some of the non-diabetic subjects completed a mixed nutrient stimulation study during the baseline and 6-month visit. Blood samples were collected immediately prior to drinking the liquid drink, and every 30 minutes after the meal ingestion for 2 hours.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Beth Israel Deaconess Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- males and females
- 18-65 years old
- approved for bariatric surgery as per BIDMC Bariatric Clinic guidelines
- English-speaking
- willing and able to take part in a multi year study involving telephone interviews and enrolled prior to bariatric surgery
Exclusion Criteria:
Any condition that would exclude a patient from bariatric surgery as listed below:
- patients with untreated major depression or psychosis
- binge eating disorders
- current drug and alcohol abuse
- severe cardiac disease with prohibitive anesthetic risks
- severe coagulopathy
- inability to comply with nutritional requirements including life-long vitamin replacement.
- pregnancy
- Any additional condition not in accordance with standard of care as per Bariatric Clinic at BIDMC.
- Any condition which in the opinion of the investigators rendered the candidate unsuitable for participation in this study.
Exclusion Criteria for Optional Biopsy:
- history of any illness, other than obesity, that may affect insulin sensitivity (diabetes anemia, infectious diseases, renal or hepatic failure, uncontrolled hypertension, cancer or lymphoma)
- subjects who required special diet prior to surgery
- chronic inflammatory conditions such as inflammatory bowel disease and rheumatoid arthritis
- states of cortisol or growth hormone excess
- any medications that are known to influence glucose metabolism such as glucocorticoids
- a known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to anesthetic agents such as Lidocaine or Novocaine
- a known history of bleeding dyscrasia or poor wound healing
- any medical condition precluding supine position
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Laparoscopic Adjustable Gastric Band
Subjects who elected to undergo Laparoscopic Adjustable Gastric Band intervention were examined prior to surgery and at 2, 3, 6 months after operation.
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Placement of a soft silicone ring with an expandable balloon in the center, around the top part of the stomach to create a two-compartment stomach, with a much smaller top part above the band.
The subject will eat enough food only to fill the top part of the stomach decreasing caloric consumption.
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Experimenteel: Roux-en-Y gastric bypass surgery
Subjects who elected to undergo Roux-en-Y gastric bypass surgery were examined prior to surgery and at 2, 3, 6 months after operation.
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Creation of a small pouch from the stomach and connection of the newly created pouch directly to the small intestine so that swallowed food bypasses most of the stomach and the first section of the small intestine.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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fasting insulin
Tijdsspanne: Change from Baseline insulin at 6 months post-surgery
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circulating levels of fasting insulin measured in pmol/L
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Change from Baseline insulin at 6 months post-surgery
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fasting glucose
Tijdsspanne: Change from Baseline insulin at 6 months post-surgery
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circulating levels of fasting glucose measured in mg/dl
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Change from Baseline insulin at 6 months post-surgery
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Boost Challenge Test
Tijdsspanne: Change from Baseline insulin at 6 months post-surgery
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serum insulin and glucose levels after a mixed meal challenge (Boost Protein shake)
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Change from Baseline insulin at 6 months post-surgery
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Christos Mantzoros, MD, PhD, Beth Israel Deaconess Medical Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2009P-000216
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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