Text Size

Two Pieces of Fruit to Type 2 Diabetics?

This study has been terminated.
(PI changed job and project was not economically viable and therefor terminated)
Sponsor:
Information provided by (Responsible Party):
Allan Stubbe Christensen, Hospitalsenheden Vest
ClinicalTrials.gov Identifier:
NCT01010594
First received: November 9, 2009
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
 Behavioral: dietary treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Two Pieces of Fruit to Type 2 Diabetics?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospitalsenheden Vest:

Primary Outcome Measures:
  • Change in Hba1c [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in bodyweight [ Time Frame: three months ] [ Designated as safety issue: No ]
  • change in serum lipids [ Time Frame: three months ] [ Designated as safety issue: No ]
  • change in fruit intake [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fruit restricted
Type 2 diabetics are advised to restrict their fruit intake to two pieces or less daily.
 Behavioral: dietary treatment
A standard dietary treatment except that they are advised to restrict their fruit intake.
Active Comparator: Fruit ad libitum
Type 2 diabetics are advised to eat at least two pieces of fruits daily
 Behavioral: dietary treatment
A standard dietary treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010594

Locations
Denmark
Department of nutrition, Regional Hospital West Jutland
Holstebro, Denmark, 7500
Sponsors and Collaborators
Hospitalsenheden Vest
Investigators
Principal Investigator: Allan S Christensen, MHSc The Department of Endocrinology and Metabolism, Aarhus University Hospital
  More Information

Publications:

Responsible Party: Allan Stubbe Christensen, MHSc, RD, Hospitalsenheden Vest
ClinicalTrials.gov Identifier: NCT01010594     History of Changes
Other Study ID Numbers: M-20090183
Study First Received: November 9, 2009
Last Updated: March 20, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 13, 2013