Pre-meal Protein Drink Improve Glycemic Regulation

Phase 2TerminatedNCT01987674

Lund University35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Pre-meal protein drinkDIETARY_SUPPLEMENT

Water drinkOTHER

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Lindsdals hälsocentral

Kalmar, Sweden

Outcomes

Primary Outcomes

HbA1c

Glycated hemoglobin

Time frame: 16 weeks

Secondary Outcomes

Postprandial glycemia

Meal challenge given at start and end of study with repeated blood glucose sampling over 2h.

Time frame: 16 weeks

Data from ClinicalTrials.gov

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