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Completed

NCT Number: NCT01680926

Metabolic Activation With Almased for Type 2 Diabetes Patients

Overweight patients with type 2 diabetes are often being treated with an intensified insulin therapy. However, in many cases, even a high insulin dosage (> 100 U per day) does not achieve satisfying metabolic control. A new therapy option is necessary that makes it possible to lower the daily insulin requirement and to improve metabolic control. The aim of this study was to investigate whether a protein-rich meal replacement is suitable to lower the daily insulin requirement and to reduce HbA1c and body weight.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

West German Center of Diabetes and Health

Düsseldorf, 40591, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with type 2 diabetes
  • BMI > 27 kg/m2
  • age 35-75 years
  • insulin therapy >100 U insulin per day

Exclusion criteria

  • contraindication for a calorie reduced diet

Treatment and study plan

Almased

Dietary Supplement

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.

Other names: Almased-Vitalkost

Primary outcomes

  1. insulin demand per day

    Time frame: 12 weeks

    daily insulin dosage

Secondary outcomes

  1. HbA1c

    Time frame: 12 weeks

    HbA1c

  2. body weight

    Time frame: 12 weeks

    body weight

Sponsors and collaborators

Lead sponsor

West German Center of Diabetes and Health

Other

Collaborators

  • Almased Wellness GmbH

Registry information

Official study title

Protein-rich Meal Replacement Significantly Reduces Weight, HbA1c and Daily Insulin Requirement Long-term in Patients With Type 2 Diabetes Mellitus and >100 U Insulin Per Day

Acronym: Almased100

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 7, 2012
Registry last updated
Sep 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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