Metabolic Activation With Protein-rich Formula Diet (AVS)

W

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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