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

May 11, 2016 updated by: Elin Östman, Lund University

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Kalmar, Sweden, 39365
        • Lindsdals hälsocentral

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-meal protein drink
A dose of 100 ml is taken just before breakfast, lunch and dinner.
Dietary supplement: Pre-meal protein drink
Placebo Comparator: Water drink
A dose of 100 ml is taken just before breakfast, lunch and dinner.
Other: Water drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 16 weeks
Glycated hemoglobin
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glycemia
Time Frame: 16 weeks
Meal challenge given at start and end of study with repeated blood glucose sampling over 2h.
16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time Frame: 16 weeks
HOMA-IR is a mathematical modelling of insulin resistance using fasting values of blood glucose and serum insulin.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Landstinget i Kalmar Län

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (Estimate)

November 19, 2013

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr2013/239-31PMB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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