METHODS: A cross-sectional study was conducted at the Klinik Kesihatan Bandar, Sungai Petani, Kedah. The inclusion criteria were patients aged ≥60 years with Type 2 Diabetes Mellitus. Those with cognitive impairment, presence of organic brain syndrome, presence of severe mental disorder and patients who are either deaf or mute were excluded. The Malay version of Geriatric Depression Scale (M-GDS-14) was used to assess the depressive symptoms. The data was analysed using descriptive statistic and multiple logistic regression.
RESULTS: A total of 511 patients participated in the study. The mean age of the respondents is 64.5 (Standard Deviation 7.0) years old. There were slightly more males (53.8%). Majority were Malay (63.0%), married (76.9%) and has a household income of less than RM1000 (67.5%). The prevalence of depression was 32.1%. The number of elderly people living with their children (Adjusted Odds Ratio, aOR0.20, 95%CI: 0.07, 0.55), elderly living with spouse, children, in law and grandchildren (aOR2.95, 95%CI: 1.18, 7.37), diabetic complication (aOR4.68, 95%CI: 2.63, 8.35) and HbA1c (aOR1.23, 95%CI: 1.09, 1.39) are significantly associated with depression.
CONCLUSION: The level of depression was found to be high. Factors contributing to the significantly high level of depression are found to be associated with living arrangements, diabetic complication and HbA1c were significantly associated with depression.
METHODS: This study will be a pilot, interventional, randomized, 2-armed, parallel, singled-masked, controlled trial. A total of 40 diabetes mellitus patients with peripheral neuropathy will be recruited and assigned randomly into 2 groups (moxibustion group and waiting group) at a 1:1 ratio. This trial consists of an 8-week intervention period and a 4-week follow-up period. During the intervention period, the moxibustion group will take 3 moxibustion sessions per week, whereas no intervention will be done on the waiting group to act as the control group. The outcome will be assessed by an outcome assessor who is unaware of the group assignment. The primary outcome will be pain assessment measured with algometry, Leeds Assessment of Neuropathic Symptoms and Signs pain scale, visual analogue scale, and neuropathy pain scale. The secondary outcome will be an evaluation of functional performance capacity with 6 minutes walking test, evaluation of the Foot and Ankle Ability Measure, and serum HbA1c and albumin levels.
DISCUSSION: We hope that this trial will provide valuable insights on the efficacy of moxibustion in the management of diabetic peripheral neuropathy.
TRIAL REGISTRATION: ClinicalTrials.gov Registry No.: NCT04894461 (URL: https://clinicaltrials.gov/ct2/show/NCT04894461?term=NCT04894461&draw=2&rank=1) Registered on May 20, 2021.
METHODS: Patients with T2D and overweight/obesity (n = 230) were randomized either into the tDNA group which included a structured low-calorie meal plan using normal foods, incorporation of diabetes-specific meal replacements, and an exercise prescription or usual T2D care (UC) for 6 months. Patients in the tDNA group also received either counseling with motivational interviewing (tDNA-MI) or conventional counseling (tDNA-CC). The UC group received standard dietary and exercise advice using conventional counseling. Eating self-efficacy was assessed using a locally validated Weight Efficacy Lifestyle (WEL) questionnaire. All patients were followed up for additional 6 months' post-intervention.
RESULTS: There was a significant change in WEL scores with intervention over one-year [Group X Time effect: F = 51.4, df = (3.4, 318.7), p<0.001]. Compared to baseline, WEL scores improved in both the tDNA groups with significantly higher improvement in the tDNA-MI group compared to the tDNA-CC and UC groups at 6 months (tDNA-MI: 25.4±2.1 vs. tDNA-CC: 12.9±2.8 vs. UC: -6.9±1.9, p<0.001). At 12 months' follow-up, both the tDNA groups maintained improvement in the WEL scores, with significantly higher scores in the tDNA-MI group than tDNA-CC group, and the UC group had decreased WEL scores (tDNA-MI: 28.9±3.1 vs. tDNA-CC: 11.6±3.6 vs. UC: -13.2±2.1, p<0.001). Patients in the tDNA-MI group with greater weight loss and hemoglobin A1C reduction also had a higher eating self-efficacy, with a similar trend observed in comparative groups.
CONCLUSION: Eating self-efficacy improved in patients with T2D and overweight/obesity who maintained their weight loss and glycemic control following a structured lifestyle intervention based on the Malaysian customized tDNA and the improvement was further enhanced with motivational interviewing.
CLINICAL TRIAL: This randomized clinical trial was registered under National Medical Research Registry, Ministry of Health Malaysia with registration number: NMRR-14-1042-19455 and also under ClinicalTrials.gov with registration number: NCT03881540.