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A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes

A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01522157
Enrollment
19
Registered
2012-01-31
Start date
2012-01-31
Completion date
2012-07-31
Last updated
2013-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Diet, Low-carbohydrate, Postprandial, Type 2 diabetes mellitus

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.

Interventions

DIETARY_SUPPLEMENTLow-fat Diet

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

DIETARY_SUPPLEMENTLow-carbohydrate Diet

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

DIETARY_SUPPLEMENTMediterranean Diet

Mediterranean Diet is provided for a breakfast and a lunch.

Sponsors

Vårdcentralen Lyckorna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diabetes mellitus type 2

Exclusion criteria

* Treatment with insulin or sulfonylurea

Design outcomes

Primary

MeasureTime frameDescription
P-glucose6 monthsmmol/l
P-Triglycerides6 monthsmmol/l

Secondary

MeasureTime frameDescription
P-Cholesterol6 monthsmmol/l
P-LDL-Cholesterol6 monthsmmol/l
P-HDL-Cholesterol6 monthsmmol/l

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026