Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DIETARY_SUPPLEMENTstringent diet regimen
DIETARY_SUPPLEMENTmoderate diet regimen
Sponsors
Almased Wellness GmbH
West German Center of Diabetes and Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
For the second part of the study, i.e. the open-label registry, 4000 subjects are anicipated.
Intervention model description
For the second part of the study, i.e. the open-label registry, there ist no randomization.
Eligibility
Sex/Gender
ALL
Age
25 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 weeks | change in hemoglobin A1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body weight | 12 weeks and 1 year | change in body weight |
| blood pressure | 12 weeks and 1 year | change in systolic and diastolic blood pressure |
| cholesterol | 12 weeks and 1 year | change in total cholesterol change in HDL cholesterol change in LDL cholesterol |
| fasting blood glucose | 12 weeks and 1 year | change in fastin g blood glucose |
| HbA1c | 1 year | change in hemoglobin A1c |
| nutrition | 12 weeks and 1 year | change in FEV (questionnaire for eating manners) |
| physical activity | 12 weeks and 1 year | change in physical activity questionnaire |
| antidiabetic medication | 12 weeks and 1 year | * absolute amount of antidiabetic medication * increase or reduction |
| quality of life | 12 weeks and 1 year | change in SF-36 quality of life questionnaire change in ADS-L (German version of the general depression scale) |
Countries
Germany
Outcome results
None listed