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NCT Number: NCT02166372

Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery

T2DM has become a major health burden for our society. More and more data support the relative effectiveness of gastrointestinal metabolic surgery, known as bariatric surgery, in the remission of T2DM of BMI less35. The metabolic surgery guidelines of IDF recommend BMI over 27.5 in Asia.

The evidence reviewed above strongly points to the need for a large randomized, controlled trial to evaluate the risks and benefits of obesity surgery in the treatment of type 2 diabetes Mellitus. This study is expected to provide very significant findings about the natural course of diabetes in obese diabetic patients.

Recruiting

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Key information

Age range

20 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Min-Sheng General Hospital

Taoyuan City, 33044, Taiwan

Location status: Recruiting

Location contact

Wei-Jei Lee, PhD

CONTACT

[email protected]

88633179599 ext. 1615

About this study

This study will recruit 200 obese T2DM patients at MSGH, for a total of 1000 in Taiwan. The inclusion criteria are those with T2DM more than 6 months, under medical management in diabetes center, BMI over 25, age between 20 and 67 years. The goals of this study are to evaluate the nature course of the diabetes for 10 years. The primary outcomes for the treatment will be assessed every year after intervention and will be composite of CVD risk factor; specifically, the proportion of patients with HbA1c < 7%, LDL cholesterol < 100 mg/dl and systolic blood pressure < 140 mmHg.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diabetic Mellitus Type 2 medically controlled at Diabetes Center for at least six months
  • BMI over 25
  • age between 20 and 67

Exclusion criteria

  • Diagnosed with cancer within past five years
  • HIV positive
  • Active TB patients
  • CV events in past six months
  • serum cretinine over 2.0 mg/dl
  • C-peptide bellow 1.0 ng/ml in past three months
  • Diabetic retinopathy; vision bellow 0.1
  • Cushing's syndrome
  • History of organ transplant
  • History of bariatric surgery
  • History of alcohol or drug dependency in past five years
  • Psychological problems likely to interfere with adherence to protocol

Treatment and study plan

Observation of natural course of Diabetes Mellitus Type 2

Other

Primary outcomes

  1. Evaluate the natural course of the diabetes of obese patients over a period of 10 years

    Time frame: ten years

Study contacts

Contact information is provided by the study sponsor or research team.

Wei-Lei Lee, PhD

CONTACT

[email protected]

88633179599 ext. 1615

Sponsors and collaborators

Lead sponsor

Min-Sheng General Hospital

Other

Registry information

Acronym: TDS

Important dates

Study start
2014
Primary completion
2024
Study completion
2034
First posted
Jun 18, 2014
Registry last updated
Jun 18, 2014

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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