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Completed

NCT Number: NCT01735253

Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients

Surgical treatment for type 2 diabetes has been taken note especially in less obese or non obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater than that of the obese.

We are trying to do a prospective observational study for the evaluation of the effect of duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.

The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral obesity, insulin use less than 10 years and the patients understanding the hypothesis of this study, risks, expecting effects and agreeing this study.

We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.

We will compare the clinical factors at each time.

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Key information

Conditions

Non Insulin Dependent Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yoonseok Heo

Incheon, 400-712, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 2 diabetes
  • HbA1C > 7.0%
  • BMI 23 - 34 or BMI 21-22 with viceral obesity
  • insulin use less than 10 years
  • uncerstanding the risks, hypothesis, expecting effects

Exclusion criteria

  • type 1 diabetes
  • C-peptide < 1.0ng/ml
  • BMI < 21
  • severe cardiovascular diseases or their history
  • malignancy or history
  • alcoholics, pituitary failrue
  • history of severe ketosis, diabetic coma or precoma
  • abnormal liver enzyme, over 3 fold of normal level
  • liver cirrhosis or hepatitis
  • serum creatinine > 2.0mg/dL
  • glucocorticoids user
  • diabetes due to other endocrine diseases
  • pancreatic disease
  • anti-GAD Ab (+)
  • the incongruity for surgery

Treatment and study plan

laparoscopic roux en Y gastric bypass / open duodenojejunal bypass

Procedure

routine GBP with 80cm roux and biliopancreatic limb

Primary outcomes

  1. Hemoglobin A1C

    Time frame: preoperatively, at 3month, at 12 month

    change of the level

Secondary outcomes

  1. oral glucose tolerance test

    Time frame: preopertively, postoperatively, at 3 month, at 12 month

    changes of the level at each time

Other outcomes

  1. insulin level

    Time frame: preoperatively, postoperatively, at 3 month, at 12 month

    change the levels

Sponsors and collaborators

Lead sponsor

Inha University Hospital

Other

Registry information

Official study title

Metabolic Surgery for Type 2 Diabetes

Acronym: T2DM

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Nov 28, 2012
Registry last updated
Nov 28, 2012

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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