Pre-meal Protein Drink Improve Glycemic Regulation (PMB/T2D)

Lund University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Pre-meal protein drink; Other: Water drink

Study type: Interventional

Funder types: Other

Identifiers

NCT01987674

Dnr2013/239-31PMB

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 2 patient groups, including a placebo group

Pre-meal protein drink

Experimental group

Description:

A dose of 100 ml is taken just before breakfast, lunch and dinner.

Treatment:

Dietary Supplement: Pre-meal protein drink

Water drink

Placebo Comparator group

Description:

A dose of 100 ml is taken just before breakfast, lunch and dinner.

Treatment:

Other: Water drink