Blood Glucose Homeostasis in Type 2 Diabetes: the Effects... | NCT00821665

Studies
Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose

NCT00821665

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Jan 13, 2009Estimated

Enrollment

39Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes
Glycemic Control

Interventions

Sucrose consumption
water consumption

Countries

Netherlands

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

Jan 2009

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

Mar 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jan 12, 2009

First Submission Date that Met QC Criteria

Jan 12, 2009

First Posted Date

Jan 13, 2009Estimated

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

Jan 12, 2009

Last Update Posted Date

Jan 13, 2009Estimated

Name	Class
Suikerstichting Nederland (Baarn)	UNKNOWN

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

Hyperglycemia forms a direct and independent risk factor for the development of cardiovascular co-morbidities in type 2 diabetes. Consumption of sucrose-sweetened soft drinks might further increase the prevalence of hyperglycemic episodes.

The objective of the study was to assess glycemic control in type 2 diabetes patients and healthy lean and obese controls under strict dietary standardization but otherwise free living conditions, with and without the consumption of soft drinks.

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

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sucrose	Experimental	Sucrose	Dietary Supplement: Sucrose consumption
Water	Placebo Comparator	Water	Dietary Supplement: water consumption

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sucrose consumption	Dietary Supplement	Sucrose	Sucrose
water consumption

Measure	Description	Time Frame
Hyperglycemia		24h

Measure	Description	Time Frame
Hyperglycemia		Postprandially

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lean NGT Group

Normoglycemic (according to 2006 ADA guidelines)
BMI < 27 kg/m2

Obese NGT Group

Normoglycemic
BMI 30- 35 kg/m2

Obese type 2 diabetes Group

BMI 30- 35 kg/m2
Oral blood glucose lowering medication

Exclusion Criteria:

Exogenous insulin use
Cardiac disease (any cardiac event in the last 5 years)
HbA1c >10%
Microalbuminuria: albumin:creatinine ratio >2,5

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 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
Luc J van Loon, Ph.D	Maastricht University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University		Maastricht	Limbrug	6200 MD	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D006943	Hyperglycemia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004326	Drinking

Ancestor Terms

ID	Term
D004435	Eating
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided