Pre-meal Protein Drink Improve Glycemic Regulation

Type 2 Diabetes Mellitus Clinical Trial

— PMB/T2D  

Official title:

Impact of a Pre-meal Protein Drink on Metabolic Markers and Glycemic Control in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01987674
• Other study ID #: Dnr2013/239-31PMB
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 12, 2013
• Last updated: May 11, 2016
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: May 2016
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Pre-meal protein drink

Other:
• Water drink

Locations

Country	Name	City	State
Sweden	Lindsdals hälsocentral	Kalmar

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Landstinget i Kalmar Län

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Homeostasis model assessment of insulin resistance (HOMA-IR)	HOMA-IR is a mathematical modelling of insulin resistance using fasting values of blood glucose and serum insulin.	16 weeks	No
Primary	HbA1c	Glycated hemoglobin	16 weeks	No
Secondary	Postprandial glycemia	Meal challenge given at start and end of study with repeated blood glucose sampling over 2h.	16 weeks	No