Two Pieces of Fruit to Type 2 Diabetics? | NCT01010594

Studies
Two Pieces of Fruit to Type 2 Diabetics?

NCT01010594

Sponsor

Hospitalsenheden Vest

Status

Terminated

Last Update Posted

Mar 21, 2013Estimated

Enrollment

64Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2

Interventions

dietary treatment
dietary treatment

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

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI changed job and project was not economically viable and therefor terminated

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Nov 9, 2009

First Submission Date that Met QC Criteria

Nov 9, 2009

First Posted Date

Nov 10, 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

Mar 20, 2013

Last Update Posted Date

Mar 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

It has been questioned whether patients with type 2 diabetes who are advised to restrict their fruit consumption to two or less pieces of fruits daily have better outcomes (HbA1c, body weight, fruit intake and serum lipids) after three months compared to patients with type 2 diabetes who are advised to eat at least two pieces of fruits.

To the investigators' knowledge, no randomized controlled trial has evaluated this.

The investigators therefore perform a randomized controlled trial including 76 patients with type 2 diabetes to investigate this.

The investigators' hypothesis is that:

Type 2 diabetics who are advised to restrict their fruit consumption have the same Hba1c three months after an initially dietary treatment as type 2 diabetics who are advised not to restrict their fruit consumption.

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fruit restricted	Active Comparator	Type 2 diabetics are advised to restrict their fruit intake to two pieces or less daily.	Behavioral: dietary treatment
Fruit ad libitum	Active Comparator	Type 2 diabetics are advised to eat at least two pieces of fruits daily	Behavioral: dietary treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dietary treatment	Behavioral	A standard dietary treatment except that they are advised to restrict their fruit intake.	Fruit restricted

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Hba1c		three months

Secondary Outcomes

Measure	Description	Time Frame
change in bodyweight		three months
change in serum lipids		three months
change in fruit intake

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients refered from a general practitioner

Exclusion Criteria:

no Hba1c when refered
Hba1c lower than 5% or higher than 12%
patients that require a translator
patients with severe cardiovascular, renal or endocrine disease
psychiatric patients
pregnant patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allan S Christensen, MHSc	The Department of Endocrinology and Metabolism, Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of nutrition, Regional Hospital West Jutland		Holstebro	Holstebro	7500	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23497350	Result	Christensen AS, Viggers L, Hasselstrom K, Gregersen S. Effect of fruit restriction on glycemic control in patients with type 2 diabetes--a randomized trial. Nutr J. 2013 Mar 5;12:29. doi: 10.1186/1475-2891-12-29.

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