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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

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 - OAT-DIAB study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033580
Enrollment
20
Registered
2024-02-06
Start date
2021-09-30
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 2 E11

Interventions

Group 1: one sequence of three consecutive oatmeal intervention days for an interventional period of three months and another three months of follow up Group 2: two sequences of three consecutive oatm

Sponsors

Universitätsklinikum Jena
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Public ContactNadine Kuniß

Universitätsklinikum Jena

nadine.kuniß@med.uni-jena.de3641 9324345

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026