Metabolic Activation With Protein-rich Formula Diet

NCT ID: NCT02230501

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2023-12-31

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.

Detailed Description

Type 2 diabetes mellitus (T2DM) patients had been randomized into two groups. During the 1st week the intervention group with stringent diet regime replaced 3 main meals by 50 g PRMR (Almased-Vitalkost, Almased Wellness GmbH, Bienenbüttel, Germany) each (=1100 kcal/day). In 2nd-4th week 2 meals were replaced and a protein-rich lunch was allowed. In 5th-12th week only dinner was replaced. The control group with moderate diet regime replaced breakfast and dinner for 4 weeks and then only dinner during the next 8 weeks. Clinical parameters were determined at the study center at baseline, after 4, 8 and 12 weeks. Primary endpoint was reduction of HbA1c, secondary endpoints reduction of weight and antidiabetic medication.

In the second part of the study type 2 diabetes patients are included in an open-label reistry and perform the lifestyle intervention with the stringent diet regime.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

moderate diet regimen

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.

Group Type: EXPERIMENTAL

moderate diet regimen

Intervention Type: DIETARY_SUPPLEMENT

stringent diet regimen

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.

Group Type: EXPERIMENTAL

stringent diet regimen

Intervention Type: DIETARY_SUPPLEMENT

Interventions

stringent diet regimen

Intervention Type: DIETARY_SUPPLEMENT

moderate diet regimen

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany); protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

For the open-label registry, the only inclusion criterium is type 2 diabetes.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almased Wellness GmbH

INDUSTRY

Sponsor Role: collaborator

West German Center of Diabetes and Health

OTHER

Sponsor Role: lead

Responsible Party

Stephan Martin

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West German Centre of Diabetes and Health

Düsseldorf, , Germany

Countries

Germany

Other Identifiers

AVS

Identifier Type: -

Identifier Source: org_study_id