Metabolic Activation With Protein-rich Formula Diet (AVS)

West German Center of Diabetes and Health

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: moderate diet regimen; Dietary Supplement: stringent diet regimen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02230501

AVS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 25 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

moderate diet regimen

Experimental group

Description:

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.

Treatment:

Dietary Supplement: moderate diet regimen

stringent diet regimen

Experimental group

Description:

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.

Treatment:

Dietary Supplement: stringent diet regimen