Mechanisms Behind Antidiabetic Effects by Gastric By-pass

NCT ID: NCT01708096

Last Updated: 2014-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-11-30

Brief Summary

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The aim of the study is to develop new strategies in treatment of continuous increasing number of patients with type 2 diabetes by understanding how bariatric surgery cures or improves this condition.

Detailed Description

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Conditions

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Diabetes Mellitus Typ 2 and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Modifast

treated with VLD Modifast 1000 kcal/day in 2 weeks before gastric by-pass,

Group Type ACTIVE_COMPARATOR

Modifast

Intervention Type DIETARY_SUPPLEMENT

2 weeks before gastric by-pass patients are treated with VLD, 1000 kcal/day

Normal diet

normal diet 2 weeks before gastric by-pass surgery

Group Type PLACEBO_COMPARATOR

Normal diet

Intervention Type DIETARY_SUPPLEMENT

normal diet 2 weeks before gastric by-pass

Interventions

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Modifast

2 weeks before gastric by-pass patients are treated with VLD, 1000 kcal/day

Intervention Type DIETARY_SUPPLEMENT

Normal diet

normal diet 2 weeks before gastric by-pass

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Diabetes typ 2
* 18-70 years
* BMI \> 35 kg/m2
* Treated with oral antidiabetic agents and/or insulin
* laparoscopic surgery

Exclusion Criteria

* Pharmacological treatment (other then above) witch could affect glucose metabolism
* open surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Anders Thorell

Assoc. Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Thorell, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, Stockholm County Council, Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2009/931-31/2

Identifier Type: -

Identifier Source: org_study_id

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