120 Participants Needed

Low-Carb Breakfast for Type 2 Diabetes

Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the low-carb breakfast treatment for type 2 diabetes?

Research shows that a big breakfast rich in protein and fat can improve blood sugar control in people with type 2 diabetes. Additionally, switching from standard cereals to slow-release starch cereals at breakfast can improve carbohydrate metabolism and reduce insulin needs, suggesting that a low-carb breakfast may be beneficial.12345

Is a low-carb breakfast safe for people with type 2 diabetes?

Research suggests that consuming a breakfast high in whole grains, cereal fiber, proteins, and unsaturated fats, while limiting rapidly available carbohydrates, is generally safe and may promote better metabolic health in people with type 2 diabetes.12346

How does the low-carb breakfast treatment for type 2 diabetes differ from other treatments?

The low-carb breakfast treatment for type 2 diabetes is unique because it focuses on reducing rapidly available carbohydrates at breakfast, which can improve insulin sensitivity and lower blood sugar levels throughout the day. This approach contrasts with other treatments that may not specifically target breakfast composition or timing.23456

Eligibility Criteria

Adults aged 18-80 with type 2 diabetes, specifically those who have an HbA1c level of 8% or higher and are willing to follow a very low-carbohydrate breakfast program. Participants must understand English, be able to consent and follow instructions, and regularly check their blood glucose levels. Excluded are those already on similar diets, involved in conflicting studies, with certain medical conditions like heart or kidney failure, untreated mental health issues, or specific dietary restrictions like veganism.

Inclusion Criteria

The ability to understand verbal and written English
Willingness to regularly check blood glucose levels as required
Your HbA1c level is 8% or higher.
See 2 more

Exclusion Criteria

You are currently on a diet that contains very few carbohydrates or you often skip breakfast.
You follow a vegan diet.
I rely on someone else to prepare my meals.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 4-month, online, very low-carbohydrate breakfast-focused program

16 weeks
Online program with regular virtual check-ins

Follow-up

Participants are monitored for changes in HbA1c, body weight, blood pressure, and other health metrics

4 weeks

Treatment Details

Interventions

  • Breakfast
Trial Overview The study is testing the impact of a very low-carbohydrate breakfast-focused diet over four months on adults with type 2 diabetes. It's online-based and will look at how well participants accept this diet plan (acceptability), can stick to it (feasibility), and its preliminary effectiveness by measuring changes in blood sugar control (HbA1c), medication needs, weight fluctuation, blood pressure variation, and cholesterol levels.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Very low-carbohydrate breakfastExperimental Treatment1 Intervention
Materials will encourage eating a very low-carbohydrate breakfast (or first meal of the day), with no more than about 5-10 non-fiber (net) grams of carbohydrates each.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Findings from Research

In a study of 59 overweight adults with type 2 diabetes, a big breakfast (rich in fat and protein) led to greater reductions in HbA1c and systolic blood pressure compared to a small breakfast (rich in carbohydrates) over 3 months.
Participants in the big breakfast group also experienced a significant reduction in their diabetes medication doses, while those in the small breakfast group were more likely to have their medication increased, indicating that a higher protein and fat breakfast may improve metabolic control in T2DM.
Big breakfast rich in protein and fat improves glycemic control in type 2 diabetics.Rabinovitz, HR., Boaz, M., Ganz, T., et al.[2015]
In a study involving 16 patients with type 2 diabetes, consuming uncooked cornstarch as a bedtime carbohydrate significantly improved glucose tolerance at breakfast the next morning, reducing the glycaemic response by 21% compared to a placebo.
In contrast, eating white bread at bedtime did not provide the same benefit, indicating that slowly digestible carbohydrates like uncooked cornstarch may be more effective for managing blood sugar levels overnight.
Breakfast glycaemic response in patients with type 2 diabetes: effects of bedtime dietary carbohydrates.Axelsen, M., Arvidsson Lenner, R., Lรถnnroth, P., et al.[2019]
In a study involving eight insulin-treated patients with non-insulin-dependent diabetes mellitus (NIDDM), two test breakfasts (meal A and meal B) produced similar plasma glucose and insulin responses, indicating comparable effects on blood sugar control.
A third breakfast (meal C) consisting of toasted muesli and skim milk resulted in significantly lower glucose and insulin responses, suggesting it may be a better option for managing post-meal blood sugar levels in diabetic patients.
Comparison of plasma glucose, serum insulin, and C-peptide responses to three isocaloric breakfasts in non-insulin-dependent diabetic subjects.Colagiuri, S., Miller, JJ., Holliday, JL., et al.[2019]

References

Big breakfast rich in protein and fat improves glycemic control in type 2 diabetics. [2015]
Breakfast glycaemic response in patients with type 2 diabetes: effects of bedtime dietary carbohydrates. [2019]
Comparison of plasma glucose, serum insulin, and C-peptide responses to three isocaloric breakfasts in non-insulin-dependent diabetic subjects. [2019]
Do all patients with type 2 diabetes need breakfast? [2016]
The effect of muesli or cornflakes at breakfast on carbohydrate metabolism in type 2 diabetic patients. [2022]
The Effects of Breakfast Consumption and Composition on Metabolic Wellness with a Focus on Carbohydrate Metabolism. [2023]
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