Diabetes Mellitus, Type 2NCT01010594
Two Pieces of Fruit to Type 2 Diabetics?
A study testing dietary treatment in people with Diabetes Mellitus, Type 2, run by Hospitalsenheden Vest at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- dietary treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients refered from a general practitioner
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of nutrition, Regional Hospital West Jutland
Holstebro, Holstebro, 7500
About this study
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.
Read more
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- dietary treatment
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary treatmentBehavioural
A standard dietary treatment except that they are advised to restrict their fruit intake.
dietary treatmentBehavioural
A standard dietary treatment.
| Study group | Role | What they receive |
|---|---|---|
| Fruit restricted | Active comparator | Type 2 diabetics are advised to restrict their fruit intake to two pieces or less daily. Receives: Behavioral: dietary treatment |
| Fruit ad libitum | Active comparator | Type 2 diabetics are advised to eat at least two pieces of fruits daily Receives: Behavioral: dietary treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hba1c
Measured: three months
Secondary outcomes (3)
change in bodyweight
Measured: three months
change in serum lipids
Measured: three months
change in fruit intake
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: PI changed job and project was not economically viable and therefor terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitalsenheden Vest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan Stubbe Christensen, Hospitalsenheden Vest
- Investigators
- Allan S Christensen, MHSc, Principal investigator, The Department of Endocrinology and Metabolism, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010594
- Sponsor's protocol ID
- M-20090183
- Status last verified
- Mar 2013
- First submitted
- 9 Nov 2009
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23497350
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Pieces of Fruit to Type 2 Diabetics?
- ClinicalTrials.gov ID
- NCT01010594
- Acronym / sponsor ID
- M-20090183
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI changed job and project was not economically viable and therefor terminated
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospitalsenheden VestUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fruit restricted | Active comparator | Behavioral: dietary treatmentType 2 diabetics are advised to restrict their fruit intake to two pieces or less daily. |
| Fruit ad libitum | Active comparator | Behavioral: dietary treatmentType 2 diabetics are advised to eat at least two pieces of fruits daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients refered from a general practitioner
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary treatmentA standard dietary treatment except that they are advised to restrict their fruit intake. | Behavioural | Fruit restricted |
| dietary treatmentA standard dietary treatment. | Behavioural | Fruit ad libitum |
Primary outcome
Change in Hba1c
Time frame: three months
3 secondary outcomes
change in bodyweight
Time frame: three months
change in serum lipids
Time frame: three months
change in fruit intake
Time frame: three months
Results and safety
The study was stopped early (reason given: PI changed job and project was not economically viable and therefor terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
- Results publication: PubMed 23497350Christensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan S Christensen, MHSc principal investigator
The Department of Endocrinology and Metabolism, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary treatment in people with Diabetes Mellitus, Type 2, run by Hospitalsenheden Vest at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI changed job and project was not economically viable and therefor terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hba1c (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01010594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013.