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OpenTrials
Completed

NCT Number: NCT00790309

Early Diabetes Resolution After Weight Loss Surgery

The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as to compare these changes to diet-induced changes in the same population.

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for surgery groups:

  • BMI of 30 kg/m2 or higher
  • Ages 18-65
  • History of impaired glucose tolerance or T2DM

Inclusion criteria

for normal weight group:

  • BMI of 30 kg/m2 or lower
  • Ages 18-65

Exclusion criteria

  • Development of an intercurrent infection
  • Prior gastric, duodenal, proximal jejunal surgery or pancreas resection
  • Current use of thiazolidinediones
  • Current use of dipeptidyl peptidase-IV inhibitors (e.g., sitagliptin) or glucagon-like peptide-1 analogs (e.g., exenatide)
  • Any condition felt by the PI or co-investigators to interfere with ability to complete the study

Treatment and study plan

Weight loss surgery

Procedure

Weight loss surgery

Laparoscopic abdominal surgeries

Procedure

laparoscopic abdominal surgeries

Primary outcomes

  1. Determine to what extent improvements in glycemic control can be attributed to caloric restriction after weight loss surgery

    Time frame: 10 days post-op

Secondary outcomes

  1. Determine changes in inflammatory markers after weight loss surgery

    Time frame: 10 days post-op

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Hormonal and Inflammatory Parameters Affecting Early Diabetes Resolution Following Weight Loss Surgery

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2008
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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