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

NCT ID: NCT00821665

Last Updated: 2009-01-13

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-09-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes Glycemic Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sucrose

Sucrose

Group Type EXPERIMENTAL

Sucrose consumption

Intervention Type DIETARY_SUPPLEMENT

Sucrose

Water

Water

Group Type PLACEBO_COMPARATOR

water consumption

Intervention Type DIETARY_SUPPLEMENT

water

Interventions

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Sucrose consumption

Sucrose

Intervention Type DIETARY_SUPPLEMENT

water consumption

water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Suikerstichting Nederland (Baarn)

UNKNOWN

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maastricht University

Principal Investigators

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Luc J van Loon, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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Maastricht University

Maastricht, Limbrug, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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07-3-004

Identifier Type: -

Identifier Source: org_study_id

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