Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to investigate if a pre-meal drink containing proteins can positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison with a placebo is included.
Interventions
DIETARY_SUPPLEMENTPre-meal protein drink
OTHERWater drink
Sponsors
Landstinget i Kalmar Län
Lund University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed type 2 diabetes mellitus according to WHO criteria (1999) * age between 30-80 years * non well controlled diabetes with HbA1c-levels above 62 mmol/mol
Exclusion criteria
* pregnant or risk of becoming pregnant * severe disease * psychological disease, dementia or mental disability that makes it impossible to retrieve informed consent of participation * liver disease * kidney malfunction (GFR \<60 or aspartate transaminase (ASAT)/alanine transaminase (ALT) two times higher than the normal interval
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 16 weeks | Glycated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial glycemia | 16 weeks | Meal challenge given at start and end of study with repeated blood glucose sampling over 2h. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Homeostasis model assessment of insulin resistance (HOMA-IR) | 16 weeks | HOMA-IR is a mathematical modelling of insulin resistance using fasting values of blood glucose and serum insulin. |
Countries
Sweden
Outcome results
None listed