Metabolic Activation With Protein-rich Formula Diet

Study Overview
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Brief Summary
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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
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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.

Official Title
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Metabolic Activation With Protein-rich Formula Diet - a Randomized-controlled Trial

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: stringent diet regimen
* Dietary Supplement: moderate diet regimen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For the second part of the study, i.e. the open-label registry, there ist no randomization.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: moderate diet regimen<br>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<br> <br> * Other names: protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany);|
| Experimental: stringent diet regimen<br>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<br> <br> * Other names: protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | change in hemoglobin A1c | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | change in hemoglobin A1c | 1 year | 
| body weight | change in body weight | 12 weeks and 1 year | 
| blood pressure | change in systolic and diastolic blood pressure | 12 weeks and 1 year | 
| cholesterol | change in total cholesterol change in HDL cholesterol change in LDL cholesterol | 12 weeks and 1 year | 
| fasting blood glucose | change in fastin g blood glucose | 12 weeks and 1 year | 
| quality of life | change in SF-36 quality of life questionnaire change in ADS-L (German version of the general depression scale) | 12 weeks and 1 year | 
| nutrition | change in FEV (questionnaire for eating manners) | 12 weeks and 1 year | 
| physical activity | change in physical activity questionnaire | 12 weeks and 1 year | 
| antidiabetic medication | absolute amount of antidiabetic medication increase or reduction | 12 weeks and 1 year |