A Randomized Controlled Trial to Assess the Feasibility and Practicability of an Oatmeal Intervention in Individuals with Type 2 Diabetes: A Pilot Study in the Outpatient Sector
Abstract
:1. Introduction
2. Materials and Methods
2.1. Intervention
2.2. Outcomes
2.3. Statistical Analysis
3. Results
3.1. Feasibility of Intervention
3.2. Practicability of Intervention
3.3. Biomedical Outcomes
3.4. Treatment Satisfaction and State of Health
3.5. Adverse Events
4. Discussion
Strengths and Limitations of This Study
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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All Participants (n = 17) | Group A (n = 10) | Group B (n = 7) | p-Value (A vs. B) | |
---|---|---|---|---|
Sex Male Female | 0.35 | |||
10 (58.8%) | 7 (70.0%) | 3 (42.9%) | ||
7 (41.2%) | 3 (30.0% | 4 (57.1%) | ||
Age (years) | 70.7 ± 7.1 | 69.3 ± 7.8 | 72.7 ± 5.8 | 0.35 |
Diabetes duration (years) | 21.5 ± 8.7 | 22.4 ± 10.3 | 20.3 ± 6.4 | 0.64 |
Insulin dosage (IU) | ||||
Total | 138 ± 35 | 139 ± 34 | 136 ± 40 | 0.85 |
Short-acting | 105 ± 37 | 107 ± 34 | 102 ± 43 | 0.77 |
Long-acting | 36 ± 27 | 32 ± 21 | 41 ± 35 | 0.53 |
Form of therapy | 0.42 | |||
ICT | 14 | 8 | 6 | |
CT | 1 | 0 | 1 | |
SIT | 1 | 1 | 0 | |
Insulin pump | 1 | 1 | 0 | |
HbA1 c (%) | 8.1 ± 0.5 | 8.0 ± 0.5 | 8.1 ± 0.6 | 0.86 |
HbA1 c (mmol/mol) | 65.03 ± (−18.03) | 63.93 ± (−18.03) | 65.03 ± (−16.94) | 0.86 |
Body weight (kg) | 103.9 ± 20.3 | 104.8 ± 18.2 | 102.5 ± 24.6 | 0.82 |
BMI (kg/m2) | 35.9 ± 5.5 | 35.6 ± 4.9 | 36.4 ± 6.7 | 0.78 |
Systolic blood pressure (mmHg) | 149 ± 20 | 146 ± 17 | 152 ± 25 | 0.55 |
Diastolic blood pressure (mmHg) | 85 ± 15 | 82 ± 11 | 89 ± 19 | 0.35 |
(1) Number of Oat-Days (3 Consecutive Days) | ||||
too many | appropriate | too few | ||
Group A | 5 | 4 | - | n = 9 |
Group B | 3 | 4 | - | n = 7 |
(2) Number of Sequences (one sequence vs. two sequences per month) | ||||
too many | appropriate | too few | ||
Group A | - | 7 | 2 | n = 9 |
Group B | 1 | 6 | - | n = 7 |
(3) Implementation in Daily Life | ||||
good | neither good nor bad | bad | ||
Group A | 4 | 4 | 1 | n = 9 |
Group B | 6 | 1 | - | n = 7 |
(4) Social Acceptance | ||||
“I would repeat OI again” | “I would not repeat OI again” | |||
Group A | 7 | 2 | n = 9 | |
Group B | 6 | 1 | n = 7 |
All Participants (n = 17) | p-Value t(0) vs. t(1) t(0) vs. t(2) | Group A (n = 10) | p-Value t(0) vs. t(1) t(0)vs. t(2) | Group B (n = 7) | p-Value t(0) vs. t(1) t(0) vs. t(2) | |
---|---|---|---|---|---|---|
Total insulin per day (IU) | ||||||
t(0) | 138 ± 35 | 139 ± 34 | 136 ± 40 | |||
t(1) | 126 ± 42 | p = 0.04 | 128 ± 46 | p = 0.12 | 125 ± 37 | p = 0.25 |
t(2) | 127 ± 42 | p = 0.05 | 135 ± 47 | p = 0.47 | 117 ± 36 | p = 0.04 |
Short-acting insulin per day (IU) | ||||||
t(0) | 105 ± 37 | 107 ± 34 | 102 ± 43 | |||
t(1) | 95 ± 41 | p = 0.03 | 101 ± 46 | p = 0.14 | 88 ± 35 | p = 0.15 |
t(2) | 95 ± 45 | p = 0.05 | 104 ± 50 | p = 0.54 | 83 ± 37 | p = 0.03 |
Long-acting insulin per day (IU) | ||||||
t(0) | 36 ± 27 | 32 ± 21 | 41 ± 35 | |||
t(1) | 31 ± 29 | p = 0.19 | 27 ± 20 | p = 0.21 | 37 ± 39 | p = 0.56 |
t(2) | 32 ± 27 | p = 0.20 | 31 ± 21 | p = 0.36 | 34 ± 36 | p = 0.31 |
HbA1 c (%) | ||||||
t(0) | 8.1 ± 0.5 | 8.0 ± 0.5 | 8.1 ± 0.6 | |||
t(1) | 7.8 ± 0.6 | p = 0.01 | 8.0 ± 0.6 | p = 0.49 | 7.6 ± 0.6 | p = 0.004 |
t(2) | 8.1 ± 0.6 | p = 0.71 | 8.0 ± 0.5 | p = 1 | 8.2 ± 0.7 | p = 0.61 |
HbA1 c (mmol/mol) | ||||||
t(0) | 65.03 ± (−18.03) | 63.93 ± (−16.94) | 65.03 ± (−16.94) | |||
t(1) | 61.75 ± (−16.94) | p = 0.01 | 63.93 ± (−16.94) | p = 0.49 | 59.56 ± (−16.94) | p = 0.004 |
t(2) | 65.03 ± (−16.94) | p = 0.71 | 63.93 ± (−16.94) | p = 1 | 66.12 ± (−15.85) | p = 0.61 |
Body weight (kg) | ||||||
t(0) | 103.9 ± 20.3 | 104.8 ± 18.2 | 102.5 ± 24.6 | |||
t(1) | 102.6 ± 20.2 | p = 0.02 | 103.1 ± 17.7 | p = 0.05 | 101.8 ± 24.8 | p = 0.35 |
t(2) | 102.6 ± 20.3 | p = 0.04 | 104.6 ± 18.4 | p = 0.63 | 99.7 ± 24.0 | p = 0.02 |
BMI (kg/m2) | ||||||
t(0) | 35.9 ± 5.5 | 35.6 ± 4.9 | 36.3 ± 6.7 | |||
t(1) | 35.5 ± 5.7 | p = 0.04 | 35.0 ± 4.9 | p = 0.05 | 36.1 ± 7.0 | p = 0.44 |
t(2) | 35.5 ± 5.7 | p = 0.05 | 35.5 ± 5.1 | p = 0.58 | 35.6 ± 6.8 | p = 0.04 |
Systolic blood pressure (mmHg) | ||||||
t(0) | 149 ± 20 | 146 ± 17 | 152 ± 25 | |||
t(1) | 146 ± 22 | p = 0.57 | 149 ± 25 | p = 0.71 | 142 ± 17 | p = 0.31 |
t(2) | 144 ± 24 | p = 0.48 | 148 ± 29 | p = 0.78 | 140 ± 16 | p = 0.34 |
Diastolic blood pressure (mmHg) | ||||||
t(0) | 85 ± 15 | 82 ± 11 | 86 ± 19 | |||
t(1) | 80 ± 16 | p = 0.28 | 82 ± 13 | p = 0.91 | 77 ± 21 | p = 0.16 |
t(2) | 80 ± 14 | p = 0.24 | 83 ± 14 | p = 0.65 | 75 ± 13 | p = 0.05 |
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Fiedler, M.; Müller, N.; Kloos, C.; Kramer, G.; Kellner, C.; Schmidt, S.; Wolf, G.; Kuniß, N. A Randomized Controlled Trial to Assess the Feasibility and Practicability of an Oatmeal Intervention in Individuals with Type 2 Diabetes: A Pilot Study in the Outpatient Sector. J. Clin. Med. 2024, 13, 5126. https://doi.org/10.3390/jcm13175126
Fiedler M, Müller N, Kloos C, Kramer G, Kellner C, Schmidt S, Wolf G, Kuniß N. A Randomized Controlled Trial to Assess the Feasibility and Practicability of an Oatmeal Intervention in Individuals with Type 2 Diabetes: A Pilot Study in the Outpatient Sector. Journal of Clinical Medicine. 2024; 13(17):5126. https://doi.org/10.3390/jcm13175126
Chicago/Turabian StyleFiedler, Michél, Nicolle Müller, Christof Kloos, Guido Kramer, Christiane Kellner, Sebastian Schmidt, Gunter Wolf, and Nadine Kuniß. 2024. "A Randomized Controlled Trial to Assess the Feasibility and Practicability of an Oatmeal Intervention in Individuals with Type 2 Diabetes: A Pilot Study in the Outpatient Sector" Journal of Clinical Medicine 13, no. 17: 5126. https://doi.org/10.3390/jcm13175126