A randomized controlled trial to assess feasibility and practicability of oatmeal intervention in metabolic impaired patients with diabetes mellitus type 2: a pilot study in the outpatient sector

Not Applicable

• Conditions: Diabetes mellitus type 2; E11; Type 2 diabetes mellitus

• Registration Number: DRKS00033580
• Lead Sponsor: niversitätsklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-08-15
• Study Start: 2024-02-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Diabetes mellitus type 2, insulin-treated
- HbA1c > 7.5% (58 mmol/mol)
from October 2022 (amendment): HbA1c > 7.0% (53 mmol/mol)
- Insulin resistance (= 1 insulin unit / kg body weight)
- Independent lifestyle
- German language in written and spoken form
- Signed consent to participate in the study

Exclusion Criteria

- Implementation of an intervention in the 12 months prior to the start of the study that corresponds to the approach of this study
- Depression
- Eating disorder
- Pregnancy/breastfeeding
- Cardiac arrhythmia
- Dementia

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility (> 70% of study cohort being successful) and practicability (assessed by protocol regarding performance aspects of intervention)

Secondary Outcome Measures

Name	Time	Method
Glycemic control (insulin doage, HbA1c, body weight, frequency of hypoglcemia) as well as treatment satisfaction (DTSQ-Questionnaire) and State of Health (EQ-5D-Questionnaire)