NCT01708096

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

October 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

4.1 years

First QC Date

October 9, 2012

Last Update Submit

March 11, 2014

Conditions

Diabetes Mellitus Typ 2 and Obesity

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Insulin sensitivity measured by hyperinsulinemic normoglycemic clamp technique

    12-18 month after gastric bypass

Secondary Outcomes (1)

  • Weight reduction

    12-18 month after gastric bypass

Other Outcomes (1)

  • Insulin signaling and glucose transport in skeletal muscle

    12-18 month after gastric by-pass

Study Arms (2)

Modifast

ACTIVE COMPARATOR

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

Dietary Supplement: Modifast

Normal diet

PLACEBO COMPARATOR

normal diet 2 weeks before gastric by-pass surgery

Dietary Supplement: Normal diet

Interventions

ModifastDIETARY_SUPPLEMENT

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

Modifast
Normal dietDIETARY_SUPPLEMENT

normal diet 2 weeks before gastric by-pass

Normal diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pharmacological treatment (other then above) witch could affect glucose metabolism
  • open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska Institutet

Stockholm, Stockholm County Council, 116 91, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anders Thorell, Assoc Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Professor

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 16, 2012

Study Start

October 1, 2009

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations

SE(2)