NCT01820273

Brief Summary

The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Also aiming for recording changes in the earliest postoperative phase.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 25, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

3.1 years

First QC Date

March 25, 2013

Last Update Submit

August 5, 2019

Conditions

Type 2 DiabetesObesity

Keywords

Type 2 diabetesBariatric surgeryincretinesGLP-1GIPgastric bypassforeguthindgut

Outcome Measures

Primary Outcomes (1)

  • changes in incretines in the bariatric patient

    standardized meals prior to pre op diet, day before surgery, first day after surgery and 6 weeks after surgery.

    2 months prior to surgery - 6 weeks post surgery

Secondary Outcomes (1)

  • Diabetes control

    6 weeks post surgery

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

female obese (BMI\>35)patients accepted for bariatric surgery (lap gastric bypass). 10 patients with type 2 diabetes(T2D) 6 10 matched controls without T2D.

You may qualify if:

  • clinical diagnosis of type 2 diabetes
  • obesity BMI \>35

You may not qualify if:

  • prior bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kalmar County Hospital

Kalmar, 39185, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bloodsamples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nils Wierup

    Lunds Universitet, Clinical researchcenter

    STUDY DIRECTOR

  • Johan Berggren, MD

    Lunds Universitet

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2013

First Posted

March 28, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2016

Study Completion

August 1, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

SE(1)