NCT02050984

Brief Summary

Bariatric surgery is generally recommended for obese people with a body mass index (BMI) of at least 40kg/m2, and for people with BMI 35 kg/m2 and serious coexisting medical conditions such as diabetes. A variety of studies showed that it cause significant weight loss, recovery from diabetes and improvement in cardiovascular risk factors, such as blood pressure. The recent guidelines suggest that patients with a BMI of more than 30 kg/m2 with co morbidities is a candidate for bariatric surgery. However, the patients with diabetes in Chinese has lower BMI than that in west country. Therefore, this research is designed to observe whether bariatric surgery reduce blood pressure in patients with diabetes and relatively lower BMI.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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, 2010

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

8.9 years

First QC Date

January 25, 2014

Last Update Submit

August 27, 2018

Conditions

ObesityDiabetes

Keywords

ObesityHypertensionBariatric SurgeryDiabetes

Outcome Measures

Primary Outcomes (1)

  • Reduction of hypertension medication prescription

    Reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after surgery.

    12 months

Secondary Outcomes (1)

  • Reduction of hypertension medication prescription

    1 month to 6 months

Other Outcomes (21)

  • Change from baseline in systolic blood pressure

    1 to 12 months

  • Change from baseline in diastolic blood pressure

    1 to 12 months

  • Change from baseline in body weight

    1 to 12 months

  • +18 more other outcomes

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with obesity and diabetes

You may qualify if:

  • Adults aged between 18 and 60 years old.
  • Type 2 Diabetes diagnosis defined according to WHO 2006 guideline.
  • Body mass index between 25.0 and 39.9 kg/m2.

You may not qualify if:

  • Hypertension ≥ 180/120 mmHg;
  • Type 1 diabetes, other types of diabetes or gestational diabetes;
  • Acute complications of diabetes;
  • Cerebrovascular diseases in the last 6 months.
  • Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 6 months.
  • Baseline psychiatric disorders: schizophrenia, bipolar disorder, severe depression, psychosis.
  • Renal diseases: diabetic nephropathy, creatinine clearance \< 30 ml/min.
  • Advanced peripheral arterial disease
  • Atrophic gastritis
  • Alcoholism or use of illicit drugs
  • Previous laparotomy
  • Severe hepatic disorders
  • Pregnancy or women not using effective contraceptive methods.
  • Recent neoplasm (\< 5 years)
  • Immunosuppressant drugs
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Related Publications (1)

  • Sun F, Zhou X, Li Q, Li Y, Zhang H, Yan Z, He H, Zhao Z, Ke Z, Gao Y, Li F, Tong W, Zhu Z. Achieving blood pressure targets and antihypertensive effects through metabolic surgery in type 2 diabetes patients with hypertension. Diabetes Metab Res Rev. 2021 May;37(4):e3422. doi: 10.1002/dmrr.3422. Epub 2020 Nov 30.

    PMID: 33197293DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

ObesityDiabetes MellitusHypertension

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Hongbo He, MD.

CONTACT

86-23-69757880cqhehongbo@gmail.com

Zhiming Zhu, MD., PhD.

CONTACT

86-23-68767881zhuzm@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the Dept. of Hypertension & Endocrinology

Study Record Dates

First Submitted

January 25, 2014

First Posted

January 31, 2014

Study Start

January 1, 2010

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

CN(1)