Beta-Cell Function After Near-Normalisation of Blood Glucose | NCT00612950

Studies
Beta-Cell Function After Near-Normalisation of Blood Glucose

NCT00612950

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Feb 12, 2008Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

glucagon-like peptide-1,
glucose dependent insulinotropic polypeptide
Saline

Countries

Denmark

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

ID	Type	Description	Link
KA 03005

Status Module

Record Verification Date

Jan 2008

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

Oct 2006

Primary Completion Date

Feb 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Jan 16, 2008

First Submission Date that Met QC Criteria

Feb 11, 2008

First Posted Date

Feb 12, 2008Estimated

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

Feb 11, 2008

Last Update Posted Date

Feb 12, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
GLP-1	Experimental	Drug: glucagon-like peptide-1,
GIP	Experimental	Drug: glucose dependent insulinotropic polypeptide
saline	Placebo Comparator	Drug: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
glucagon-like peptide-1,	Drug	GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.	GLP-1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
2.phase insulin response measured as incremental area under the curve from 10-120 minutes		2 hours

Secondary Outcomes

Measure	Description	Time Frame
2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment		2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-70 years
Type 2 diabetes diagnosed after 30 years of age
BMI > 25

Exclusion Criteria:

Severe complications to diabetes
Abnormal liver and kidney function
Haemoglobin below the lower limit
Macroalbuminuria
Systemic disease
Pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patricia V Højberg, MD, PHD	University Hospital Hvidovre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Endocrinology, Hvidovre Hospital		Copenhagen			Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19037628	Derived	Hojberg PV, Vilsboll T, Rabol R, Knop FK, Bache M, Krarup T, Holst JJ, Madsbad S. Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes. Diabetologia. 2009 Feb;52(2):199-207. doi: 10.1007/s00125-008-1195-5. Epub 2008 Nov 27.

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

ID	Term
D052216	Glucagon-Like Peptide 1
D054795	Incretins
D012965	Sodium Chloride

ID	Term
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones