NCT01522157

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 2, 2013

Status Verified

November 1, 2013

Enrollment Period

6 months

First QC Date

January 17, 2012

Last Update Submit

November 29, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

DietLow-carbohydratePostprandialType 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

  • P-glucose

    mmol/l

    6 months

  • P-Triglycerides

    mmol/l

    6 months

Secondary Outcomes (3)

  • P-Cholesterol

    6 months

  • P-LDL-Cholesterol

    6 months

  • P-HDL-Cholesterol

    6 months

Study Arms (1)

All test patients

ACTIVE COMPARATOR

All test patients are given low-fat, low-carbohydrate and mediterranean diet, in randomised order on different days.

Dietary Supplement: Low-fat DietDietary Supplement: Low-carbohydrate DietDietary Supplement: Mediterranean Diet

Interventions

Low-fat DietDIETARY_SUPPLEMENT

Low-fat Diet is provided for a breakfast and a lunch.

All test patients
Low-carbohydrate DietDIETARY_SUPPLEMENT

Low-carbohydrate Diet is provided for a breakfast and a lunch.

All test patients
Mediterranean DietDIETARY_SUPPLEMENT

Mediterranean Diet is provided for a breakfast and a lunch.

All test patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus type 2

You may not qualify if:

  • Treatment with insulin or sulfonylurea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical and Health Sciences, Linköping University

Linköping, S-59183, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 24312178RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Fat-RestrictedDiet, Carbohydrate-RestrictedDiet, Mediterranean

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet, Plant-Based

Study Officials

  • Fredrik H Nystrom, Professor

    Department of Endocrinology Linköping University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 31, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 2, 2013

Record last verified: 2013-11

Locations

SE(1)