NCT01317979

Brief Summary

Type 2 Diabetes Mellitus (T2DM) is a serious health problem that has increased dramatically worldwide due to the high and increasing prevalence of obesity. Medical management of T2DM is of limited success. Because not well controlled T2DM patients are in high risk of blindness, cardiovascular accident and end staged disease, T2DM has become a major health burden for society. Recent data on the relative effectiveness of gastrointestinal metabolic surgery played as bariatric surgery in the remission of T2DM, suggests that it may be significantly more effective than current medical treatment. In considering that less than half of the T2DM patients can achieve satisfactory treatment goal under current medical treatment, gastrointestinal metabolic surgery shall play an important role in T2DM treatment in the future. However, the indication for metabolic surgery and clinical predictors of success are not clear now. These clinical predictors can help us to choose appropriate not-well controlled T2DM patients to receive metabolic surgery and reduce dverse health outcomes in those patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 18, 2011

Status Verified

March 1, 2011

Enrollment Period

1.2 years

First QC Date

March 2, 2011

Last Update Submit

March 17, 2011

Conditions

Study Arms (1)

Diabetes group I

metabolic surgery, laparoscopicly

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1. Age between 18 to 65. 2. Type 2 DM \> 6 months, HbA1C\>7.0% under treatment 3. Body mass index \>25 kg/m2 4. could follow up

You may qualify if:

  • Age between 18 to 65.
  • Type 2 DM \> 6 months, HbA1C\>8.0% under treatment
  • Body mass index \>25 kg/m2
  • could follow up

You may not qualify if:

  • Age \<18 or \>65
  • HbA1C \< 7%
  • BMI \< 25 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Min sheng general hospital

Taoyuan, Taiwan

RECRUITING

MinSheng Genral Hospital

Taoyuan District, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum stored at a -85 ℃ refrigerator

MeSH Terms

Conditions

DiseaseEndocrine System DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jun Juin Tsou, university

    Metabolic surgery center,Minsheng general hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 18, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2012

Study Completion

December 1, 2013

Last Updated

March 18, 2011

Record last verified: 2011-03

Locations