Pre-meal Protein Drink Improve Glycemic Regulation
Phase 1
Terminated
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Dietary Supplement: Pre-meal protein drinkOther: Water drink
- Registration Number
- NCT01987674
- Lead Sponsor
- Lund University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pre-meal protein drink Pre-meal protein drink A dose of 100 ml is taken just before breakfast, lunch and dinner. Water drink Water drink A dose of 100 ml is taken just before breakfast, lunch and dinner.
- Primary Outcome Measures
Name Time Method HbA1c 16 weeks Glycated hemoglobin
- Secondary Outcome Measures
Name Time Method Postprandial glycemia 16 weeks Meal challenge given at start and end of study with repeated blood glucose sampling over 2h.
Trial Locations
- Locations (1)
Lindsdals hälsocentral
🇸🇪Kalmar, Sweden