Metabolic Activation With Protein-rich Formula Diet

NCT02230501 | Completed

• 1 other identifier: AVS
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT 01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting \>100 IE insulin/day. The aim of the present study was to investigate in a randomized-controlled trial if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or insulin. A second part of the study is an open-label registry for persons with type 2 diabetes, who will perform the lifestyle intervention with the stringent diet regime.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  change in hemoglobin A1c

  12 weeks

Secondary Outcomes (9)

• HbA1c

  1 year

• body weight

  12 weeks and 1 year

• blood pressure

  12 weeks and 1 year

• cholesterol

  12 weeks and 1 year

• fasting blood glucose

  12 weeks and 1 year

Study Arms (2)

moderate diet regimen

EXPERIMENTAL

Week 1-4: replacement of breakfast and dinner with 1g PRMR /kg normal weight (=height in cm-100), a protein-rich lunch was allowed Week 5-12: replacement of dinner For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.

Dietary Supplement: moderate diet regimen

stringent diet regimen

EXPERIMENTAL

Week 1: replacement of 3 main meals by 1g PRMR / kg normal weight (=height in cm - 100) Week 2-4: replacement of breakfast and dinner, a protein-rich lunch was allowed Week 5-12: replacement of dinner For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.

Dietary Supplement: stringent diet regimen

Interventions

stringent diet regimen DIETARY_SUPPLEMENT

Also known as: protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)

stringent diet regimen

moderate diet regimen DIETARY_SUPPLEMENT

Also known as: protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)

moderate diet regimen

Eligibility Criteria

• Age: 25 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus
• HbA1c \> 7,5%
• Body Mass Index (BMI) ≥ 27,5 kg/m2

You may not qualify if:

• acute infections
• severe diseased with hospital stay during the last 3 months
• chronic diseases
• chemotherapy or cortisone treatment
• weight loss of more than 2 kg per week during the last month
• smoking cessation during the last 3 months or planned
• weight-influencing medication
• pregnancy, breast-feeding or lack of contraception
• high-level physical activity of more than 1h per day
• incompatibility with components of the PRMR
• participation in an other study during the last 6 months

Sponsors & Collaborators

• West German Center of Diabetes and Health: lead
• Almased Wellness GmbH: collaborator

Study Sites (1)

West German Centre of Diabetes and Health

Düsseldorf, 40591, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For the second part of the study, i.e. the open-label registry, 4000 subjects are anicipated.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: For the second part of the study, i.e. the open-label registry, there ist no randomization.

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: September 3, 2014
• Study Start: February 1, 2011
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

DE (1)