NCT02230501Completed
Metabolic Activation With Protein-rich Formula Diet
Metabolic Activation With Protein-rich Formula Diet - a Randomized-controlled Trial
Source: ClinicalTrials.gov · Last updated 23 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 26 Aug 2014
- Start date
- Feb 2011
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- West German Center of Diabetes and Health
- Diseases
- Type 2 diabetes
- NCT number
- NCT02230501
What you commit to
- Study type: Interventional
- Participants enrolled: 300
- From Feb 2011 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- chemotherapy or cortisone treatment
- weight-influencing medication
Other illness
- acute infections
- chronic diseases
- participation in an other study during the last 6 months
- For the open-label registry, the only inclusion criterium is type 2 diabetes.
Other
- severe diseased with hospital stay during the last 3 months
- weight loss of more than 2 kg per week during the last month
- smoking cessation during the last 3 months or planned
- pregnancy, breast-feeding or lack of contraception
- high-level physical activity of more than 1h per day
- incompatibility with components of the PRMR
Who the study is looking for
- Type 2 diabetes mellitus
- HbA1c \> 7,5%
- Body Mass Index (BMI) ≥ 27,5 kg/m2
Age in the registry: 25 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West German Centre of Diabetes and Health Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.