Pre-meal Protein Drink Improve Glycemic Regulation

Phase 1

Terminated

• Conditions: Type 2 Diabetes Mellitus

• 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

Study Timeline

• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-19
• Study Start: 2014-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

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

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