(R33 Phase) DELISH Study: Diabetes Education to Lower Insulin, Sugars, and Hunger (NCT03837405) | Clinical Trial Compass
CompletedNot Applicable
(R33 Phase) DELISH Study: Diabetes Education to Lower Insulin, Sugars, and Hunger
United States125 participantsStarted 2018-12-12
Plain-language summary
The investigators plan an R33 phase trial in which 120 persons with type 2 diabetes (T2DM) will be randomized (using a 1:1 ratio) to education alone (Ed) on following a carbohydrate restricted diet for T2DM, or this same education content with added mindful eating/Mindfulness-Based Intervention components (Ed+MBI).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. History of T2DM mellitus.
. HbA1c ≥ 6.5% and \< 12.0% at screening.
. Experience food-related cravings most days of the week and eat in response to these cravings regularly.
. Aged 18 years old and older.
. Able to engage in light physical activity.
. Willing and able to participate in the interventions including appropriate participation in the group setting.
. Have smartphone and are willing to use it on a regular basis for data collection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study compared diets in people with Type 2 diabetes and measured adherence using ketone levels and carbohydrate tracking — now that the trial is completed, has any data been published, and what did it show about whether a very low-carb diet is actually realistic to stick to long-term?
2The trial tracked whether participants could stay under 50 grams of non-fiber carbohydrate per day — is that level of carb restriction something you think would be safe or practical for my specific situation, including any medications I'm on that might interact with a ketogenic-style diet?
3Since this was a research phase focused on measuring diet adherence rather than long-term health outcomes like blood sugar control or weight loss, what do you think the evidence currently says about the actual health benefits of a very low-carb approach for managing my Type 2 diabetes?
4The study used blood ketone levels of 0.5 mmol/L or higher as a marker of diet adherence — could you help me understand the difference between nutritional ketosis at that level and diabetic ketoacidosis, and whether monitoring ketones would be something I'd need to do if I tried a similar diet?
5Now that this trial is completed, are there other ongoing or more recent studies on low-carb diets for Type 2 diabetes that might be worth exploring, or is there a standard-of-care dietary approach you'd recommend I consider first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diet Adherence Between Intervention Arms as Measured by % of Ketones >= 0.5 mmol/L
Timeframe: Measures from ketone measure initiation (week 5) to 12 months. Ketones were measured daily over 7 days at 5 study timepoints: 5 weeks, 3, 6, 9, and 12 months.
2
Diet Adherence Between Intervention Arms as Measured by % of Participants in Each Arm With < 50 Grams/Day of Non-fiber Carbohydrate on 24- Hour Diet Recall
Timeframe: Average of three measures, done at 3, 6 and 12 months
. A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention, that may need immediate changes in medical management that will affect study outcome measures, or that may require important adaptations in the study diet.
. Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum.
. Current use of weight loss medications, such as Alli or amphetamine-based drugs that may affect weight.
. Planned or history of weight-loss (bariatric) surgery, or other intestinal surgeries that cause malabsorption. These are likely to change study outcome measures, making it difficult to distinguish the effects of the intervention program, or require extensive tailoring of the diet intervention.
. Currently enrolled in a weight loss program, such as Weight Watchers or a self-help group such as Overeaters Anonymous, or have unalterable plans to enroll in one of these programs in the next year; using a ketogenic low carbohydrate diet in the past 6 months with advice from a health care professional; or use of a mindful eating program with guidance from a professional in the past 6 months or have ever used the study mindful-eating app.
. Vegan or vegetarian.
. Unwilling to do regular blood testing at home for glucose or ketone monitoring.