Type 2 Diabetes MellitusNCT01522157
A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes
A study testing Low-fat Diet, Low-carbohydrate Diet and Mediterranean Diet in people with Type 2 Diabetes Mellitus, run by Vårdcentralen Lyckorna at 1 site in Sweden.
Trial summary
The trial will study the acute metabolic effects of three different types of diet: low-fat diet, low-carbohydrate diet and Mediterranean diet. About 20 patients with diabetes mellitus type 2 will be recruited and each of them will be given each type of diet on three different days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Low-fat Diet, Low-carbohydrate Diet and Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2012to Jul 2012
- 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
- Diabetes mellitus type 2
Who cannot join
- Treatment with insulin or sulfonylurea
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Medical and Health Sciences, Linköping University
Linköping, S-59183
About this study
The trial will study the acute metabolic effects of three different types of diet: low-fat diet, low-carbohydrate diet and Mediterranean diet. About 20 patients with diabetes mellitus type 2 will be recruited and each of them will be given each type of diet on three different days. Menus with the same energy content but with different content of fat, carbohydrate and protein are designed. Breakfast and lunch are served for the patients each day of testing. Laboratory samplings are performed six times during the day. The order of the dietary intervention is randomized for each patient.
The investigators suppose to find different reaction in plasma glucose and lipids depending on the type of diet.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Low-fat Diet, Low-carbohydrate Diet, Mediterranean Diet
- Keywords
- Diet, Low-carbohydrate, Postprandial, Type 2 diabetes mellitus
- 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.
Low-fat DietDietary supplement
Low-fat Diet is provided for a breakfast and a lunch.
Low-carbohydrate DietDietary supplement
Low-carbohydrate Diet is provided for a breakfast and a lunch.
Mediterranean DietDietary supplement
Mediterranean Diet is provided for a breakfast and a lunch.
| Study group | Role | What they receive |
|---|---|---|
| All test patients | Active comparator | All test patients are given low-fat, low-carbohydrate and mediterranean diet, in randomised order on different days. Receives: Dietary Supplement: Low-fat Diet; Dietary Supplement: Low-carbohydrate Diet; Dietary Supplement: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
P-glucose
mmol/l
Measured: 6 months
P-Triglycerides
mmol/l
Measured: 6 months
Secondary outcomes (3)
P-Cholesterol
mmol/l
Measured: 6 months
P-LDL-Cholesterol
mmol/l
Measured: 6 months
P-HDL-Cholesterol
mmol/l
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionJul 2012
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 Type 2 Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vårdcentralen Lyckorna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans Guldbrand, Vårdcentralen Lyckorna
- Investigators
- Fredrik H Nystrom, Professor, Principal investigator, Department of Endocrinology Linköping University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522157
- Sponsor's protocol ID
- Dnr 2011/418-31
- Status last verified
- Nov 2013
- First submitted
- 17 Jan 2012
- Last updated
- 2 Dec 2013
- Results posted
- No
Publications
Fernemark H, Jaredsson C, Bunjaku B, Rosenqvist U, Nystrom FH, Guldbrand H. A randomized cross-over trial of the postprandial effects of three different diets in patients with type 2 diabetes. PLoS One. 2013 Nov 27;8(11):e79324. doi: 10.1371/journal.pone.0079324. eCollection 2013.
PubMed 24312178
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01522157
- Acronym / sponsor ID
- Dnr 2011/418-31
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diet, Low-carbohydrate, Postprandial, Type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vårdcentralen LyckornaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 31 Jan 2012 (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.
The trial will study the acute metabolic effects of three different types of diet: low-fat diet, low-carbohydrate diet and Mediterranean diet. About 20 patients with diabetes mellitus type 2 will be recruited and each of them will be given each type of diet on three different days. Menus with the same energy content but with different content of fat, carbohydrate and protein are designed. Breakfast and lunch are served for the patients each day of testing. Laboratory samplings are performed six times during the day. The order of the dietary intervention is randomized for each patient.
The investigators suppose to find different reaction in plasma glucose and lipids depending on the type of diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All test patients | Active comparator | Dietary Supplement: Low-fat Diet, Dietary Supplement: Low-carbohydrate Diet, Dietary Supplement: Mediterranean DietAll test patients are given low-fat, low-carbohydrate and mediterranean diet, in randomised order on different days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetes mellitus type 2
Key exclusion criteria (1 listed)
- Treatment with insulin or sulfonylurea
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 |
|---|---|---|
| Low-fat DietLow-fat Diet is provided for a breakfast and a lunch. | Dietary supplement | All test patients |
| Low-carbohydrate DietLow-carbohydrate Diet is provided for a breakfast and a lunch. | Dietary supplement | All test patients |
| Mediterranean DietMediterranean Diet is provided for a breakfast and a lunch. | Dietary supplement | All test patients |
Primary outcome
P-glucose
Time frame: 6 months
mmol/l
P-Triglycerides
Time frame: 6 months
mmol/l
3 secondary outcomes
P-Cholesterol
Time frame: 6 months
P-LDL-Cholesterol
Time frame: 6 months
P-HDL-Cholesterol
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2013.
- Results publication: PubMed 24312178Fernemark H, Jaredsson C, Bunjaku B, Rosenqvist U, Nystrom FH, Guldbrand H. A randomized cross-over trial of the postprandial effects of three different diets in patients with type 2 diabetes. PLoS One. 2013 Nov 27;8(11):e79324. doi: 10.1371/journal.pone.0079324. eCollection 2013.
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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.
Fredrik H Nystrom, Professor principal investigator
Department of Endocrinology Linköping 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 Low-fat Diet, Low-carbohydrate Diet and Mediterranean Diet in people with Type 2 Diabetes Mellitus, run by Vårdcentralen Lyckorna at 1 site in Sweden.
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 1 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: finished, as of the sponsor's last update on 2 Dec 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
P-glucose (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT01522157, 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 2 Dec 2013.