Type 2 Diabetes
Conditions
Keywords
Very low carbohydrate diet, Nutrition therapy
Brief summary
The investigators will conduct an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, very low-carbohydrate breakfast-focused program in 120 adults with type 2 diabetes. The investigators will measure acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids.
Detailed description
More than 15% of U.S. adults with type 2 diabetes have poorly controlled blood gluocse, here defined as a glycated hemoglobin (HbA1c) level of 7.0% or higher. These adults have an elevated health risk of a variety of outcomes, including amputation and mortality from cardiovascular disease and from all causes. Nutrition- focused interventions can be effective for improving glycemic control, reducing anti-hyperglycemic medications, and reducing body weight, all of which are critical outcomes for adults with type 2 diabetes. However, typical nutrition-focused interventions can be burdensome, often requiring complex instructions and a complete overhaul of one's diet. Additionally, adults with poorly controlled type 2 diabetes are more likely to have low literacy levels, which can be a barrier for adherence to complex interventions. Therefore, an effective intervention for adults with poorly controlled diabetes who may have lower health literacy levels is necessary to reduce both HbA1c levels and anti-hyperglycemic medications. Carbohydrate intake has the strongest impact on post-prandial glycemia of any dietary factor, and a very low-carbohydrate diet-due to its ability to improve glycemic control-is now recommended by the American Diabetes Association (ADA) for the treatment of type 2 diabetes. The investigators hypothesize that some of the benefits of a very low-carbohydrate diet may be available to individuals who change only their breakfasts to be very low-carbohydrate, rather than modifying their entire diet. Thus, the investigators will conduct an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, small- steps, low-literacy, very low-carbohydrate breakfast-focused program in 120 adults with poorly controlled type 2 diabetes. The investigators will measure acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids. The investigators will also test whether factors such as sex, health literacy level, and baseline insulin resistance significantly moderate the impact of the intervention on change in HbA1c and change in anti-hyperglycemic medications.
Interventions
BEHAVIORALBreakfast
We will provide participants recipes and information to support this dietary change.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blood tests and continuous glucose monitoring are masked.
Intervention model description
All participants will be provided the same intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* HbA1c 7% or higher * 18-80 years old * The ability to understand verbal and written English * Willingness to follow the prescribed diet * Able to consent and follow directions * Willingness to regularly check blood glucose levels as required
Exclusion criteria
* Inability to provide informed consent * Pregnant, breastfeeding, or planning for either in the next 6 months or \<6 months postpartum * Low C-peptide and possible subsequent GAD 65 level that suggests type 1 diabetes, clinical factors that suggest type 1 diabetes (lean, lack of family history, and diabetic ketoacidosis in the past) or a previous diagnosis of type 1 diabetes or latent autoimmune diabetes * Cancer, heart failure, or kidney failure * Vegan * Untreated mental health condition * Currently following a very low-carbohydrate diet or breakfasts * Thyroid levels out of range * Alcoholism * Previous bariatric surgery * Difficulty chewing or swallowing * Dependence on others for food preparation * Currently enrolled in another investigative study that might conflict with this research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention satisfaction | At 4 months | A 1-item measure about intervention satisfaction. We ask participants, How would you rate your overall satisfaction with the program? The item is rated from 1 = very dissatisfied to 6 = very satisfied, with higher scores reflecting greater satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weekly dietary adherence | Weekly over 4 months | A 1-item measure about dietary adherence. We ask participants to reflect on the past week and rate whether they ate a low-carbohydrate breakfast. The item is rated from 1 = not at all to 7 = very much so, with higher scores reflecting greater adherence. |
| Change in diabetes treatment satisfaction | 0 to 4 months | The Diabetes Treatment Satisfaction Questionnaire is an 8-item measure of satisfaction with current diabetes therapy over the past several weeks. Each item is rated on a 7-point scale. Six items form the Treatment Satisfaction scale, assessing overall satisfaction, perceived convenience and flexibility, understanding of diabetes, and willingness to recommend or continue the current regimen. Two additional items evaluate the perceived frequency of unacceptable hyperglycemia and hypoglycemia. The Treatment Satisfaction score is calculated from the six satisfaction items, with higher scores indicating greater satisfaction; the two frequency items are scored separately, with higher values reflecting more frequent high or low blood glucose levels. |
| Change in health-related quality of life | 0 to 4 months | The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 is a 29-item survey for assessing health-related quality of life across seven domains (Physical function, Anxiety, Depression, Fatigue, Sleep disturbance, Social roles, and Pain interference) plus Pain intensity. All domains are scored using T-scores (mean 50, SD 10), where higher scores indicate better function for functional domains (Physical Function, Social Roles) and worse symptoms for symptom domains (Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference). |
| Change in HbA1c | 0 to 4 months | This will assess the change in the level reported for this outcome |
| Change in anti-hyperglycemic medications | 0 to 4 months | The Medication Effect Score (MES) quantifies the overall intensity of antiglycemic therapy, with higher scores indicating greater medication requirements. For each diabetes medication, the percentage of the maximum recommended daily dose is multiplied by an adjustment factor reflecting its expected hemoglobin A1c-lowering potency; these values are summed to yield the total MES. Scores range from 0 upward (no fixed maximum), with lower scores reflecting lower medication intensity. |
Countries
United States
Outcome results
None listed