Exercise and Acarbose in Type 2 Diabetes | NCT01244971

Studies
Exercise and Acarbose in Type 2 Diabetes

NCT01244971

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Nov 22, 2010Estimated

Enrollment

62Actual

Phase

Phase 4

Conditions

Diabetes Mellitus Type 2

Interventions

Acarbose
Exercise
Exercise + Acarbose

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2003

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Jun 2004Actual

Completion Date

Not provided

First Submitted Date

Nov 19, 2010

First Submission Date that Met QC Criteria

Nov 19, 2010

First Posted Date

Nov 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2010

Last Update Posted Date

Nov 22, 2010Estimated

Name	Class
The Swedish Research Council	OTHER_GOV
Bayer	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to investigate the impact of exercise training, Acarbose, and the combination of exercise and Acarbose on glycemic control, body composition, insulin sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle biopsies will be obtain to study gene expression. Our hypothesis is that the combination therapy will be superior to monotherapy with exercise or Acarbose.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Acarbose	Active Comparator	Drug: Acarbose
Exercise	Active Comparator	Behavioral: Exercise
Exercise + Acarbose	Experimental	Other: Exercise + Acarbose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acarbose	Drug	100mg, 3 times daily	Acarbose
Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycemic control	Glycated A1c	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Men and women, diagnosis of type 2 diabetes established since at least three months, treatment with diet or maximum one oral anti-diabetic drug, GHb < 8.5 %, age 45 - 60 years, BMI 25 - 30 kg/m2, no participation in any regular exercise program.

Exclusion Criteria: Unable to perform exercise, significant GI-disease, severe heart-disease, renal failure

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suad Efendic, Professor	Dpt of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Enheten för Metabol Kontroll, Endokrinkliniken, Karolinska University Hospital		Stockholm	Stockholm County	17176	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16801564	Result	Wagner H, Degerblad M, Thorell A, Nygren J, Stahle A, Kuhl J, Brismar TB, Ohrvik J, Efendic S, Bavenholm PN. Combined treatment with exercise training and acarbose improves metabolic control and cardiovascular risk factor profile in subjects with mild type 2 diabetes. Diabetes Care. 2006 Jul;29(7):1471-7. doi: 10.2337/dc05-2513.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D014312	Trisaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates