Completed

Almased100Protein-rich Meal Replacement for Weight and HbA1c Reduction in Type 2 Diabetes Patients on High Insulin Dosage

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Study Aim

This early phase study aims to evaluate if a protein-rich meal replacement can reduce daily insulin demand and improve HbA1c levels in individuals with type 2 diabetes who are on high insulin dosage.

What is being tested

Almased

Dietary Supplement
Who is being recruted

Diabetes Mellitus+8

+ Endocrine System Diseases

+ Hyperinsulinism

From 35 to 75 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Early Phase 1
Interventional
Study Start: July 2009
See protocol details

Summary

Principal SponsorWest German Center of Diabetes and Health
Last updated: September 11, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2009

Actual date on which the first participant was enrolled.

The pilot study included patients with type 2 diabetes (n=22), that injected >100 U insulin daily. During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced. Clinical parameters were determined at the beginning of the study, after 4, 8 and 12 weeks as well as after 1.5 years of follow-up. Wilcoxon signed rank test was used for the intention-to-treat analysis and Mann-Whitney test for subgroup analyses.

NCT01680926
Principal SponsorWest German Center of Diabetes and Health
Last updated: September 11, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

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

22 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 35 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesHyperinsulinismMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersBody WeightDiabetes Mellitus, Type 2Insulin Resistance

Criteria

4 inclusion criteria required to participate
BMI > 27 kg/m2
age 35-75 years
insulin therapy > 100 U insulin per day
patients with type 2 diabetes
1 exclusion criteria prevent from participating
contraindication for a calorie reduced diet

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

West German Center of Diabetes and Health

Düsseldorf, GermanyOpen West German Center of Diabetes and Health in Google Maps
CompletedOne Study Center