NCT01987674

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.5 years

First QC Date

November 12, 2013

Last Update Submit

May 11, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Glycated hemoglobin

    16 weeks

Secondary Outcomes (1)

  • Postprandial glycemia

    16 weeks

Other Outcomes (1)

  • Homeostasis model assessment of insulin resistance (HOMA-IR)

    16 weeks

Study Arms (2)

Pre-meal protein drink

EXPERIMENTAL

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

Dietary Supplement: Pre-meal protein drink

Water drink

PLACEBO COMPARATOR

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

Other: Water drink

Interventions

Pre-meal protein drinkDIETARY_SUPPLEMENT
Pre-meal protein drink
Water drinkOTHER
Water drink

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lindsdals hälsocentral

Kalmar, 39365, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 19, 2013

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

SE(1)