Fasting for Type 1 Diabetes

Overseen By Alyssa Randolph

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Must not be taking: Steroids, Beta-blockers

Disqualifiers: Pregnancy, Smoking, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how fasting affects blood sugar control in people with type 1 diabetes, particularly during episodes of low blood sugar. Researchers seek to determine if fasting alters the body's response to insulin, which is crucial for diabetes management. Participants will be divided into two groups: one will fast, and the other will consume regular meals before testing. Individuals with type 1 diabetes who are not obese and are C-peptide negative (indicating no insulin production) may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to scientific knowledge and potentially enhance diabetes management strategies.

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

You may need to stop certain medications, especially if you are taking steroids for inflammation or medications that affect adrenergic signaling, like beta-blockers or bronchodilators. The trial does not specify other medications, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fasting can be safe for people with type 1 diabetes. Some studies suggest that fasting might reduce the need for insulin, benefiting diabetes management. One study found that different fasting methods, such as intermittent fasting, can be safe and effective for weight loss in people with type 1 diabetes. This indicates that fasting might aid in weight management and be well-tolerated.

In this trial, researchers are comparing fasting with regular meals to assess their effects on blood sugar control. Although past research is promising, consulting a healthcare provider before altering a diabetes management plan is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how fasting and feeding affect blood sugar management in people with Type 1 diabetes. Unlike traditional approaches that rely heavily on insulin therapy and careful monitoring, this trial looks at how meal timing and fasting might play a role in preventing hypoglycemia, a common and dangerous complication. By comparing fasting with normal eating patterns before insulin administration, they hope to uncover new insights into how diet can impact diabetes management and potentially open up new avenues for less medication-dependent strategies.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes?

This trial will compare the effects of fasting and feeding in individuals with type 1 diabetes. Research has shown that fasting can benefit people with type 1 diabetes. Studies have found that fasting may reduce the need for extra insulin, the primary treatment for diabetes. In some cases, fasting also helps lower blood sugar levels and body weight. Maintaining stable blood sugar levels is crucial for managing diabetes. Although more research is needed, these findings suggest that fasting might help control diabetes. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for non-obese individuals with type 1 diabetes, who have a C-peptide negative status. It's open to all genders and ethnicities, provided they don't smoke or have complications like neuropathy, retinopathy, nephropathy, HIV/hepatitis, cardiovascular diseases or are on certain medications like steroids or beta-blockers.

Inclusion Criteria

My gender or race does not limit my participation.

I have been diagnosed with type 1 diabetes.

You do not produce C-peptide.

Exclusion Criteria

I have heart or blood vessel disease.

I do not have HIV or hepatitis.

I am currently taking medication for heart or lung issues, like beta-blockers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Trial 1: Feeding

Participants eat an isocaloric breakfast and lunch prior to an insulin-induced hypoglycemic challenge

1 day

1 visit (in-person)

Trial 2: Fasting

Participants remain fasted prior to an insulin-induced hypoglycemic challenge

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the hypoglycemic challenges

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fasting
• Feeding

Trial Overview The study investigates how fasting affects the body's response to low blood sugar in people with type 1 diabetes. Participants will undergo periods of fasting and feeding to see how these states influence their hormonal and liver responses during insulin-induced hypoglycemia.

How Is the Trial Designed?

Group I: Feeding Experimental Treatment 1 Intervention

Subjects will eat a normal breakfast and lunch prior to insulin-induced hypoglycemia.

Group II: Fasting Experimental Treatment 1 Intervention

Subjects will remain fasted prior to insulin-induced hypoglycemia.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10459496/

Efficacy of Fasting in Type 1 and Type 2 Diabetes Mellitus Published research assessing the effect of fasting in T1DM has demonstrated positive outcomes, including a reduced need for exogenous insulin [8] ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1751991825000464

Intermittent fasting versus continuous caloric restriction for ... IF shown substantial short-term advantages, encompassing marked decreases in HbA1c levels, fasting glucose, and body weight. Mechanistic discoveries emphasized ...

3. bmj.com bmj.com/content/389/bmj-2024-082007

Intermittent fasting strategies and their effects on body ... The current evidence provides some indication that intermittent fasting diets have similar benefits to continuous energy restriction for weight loss and ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820237

A 5:2 Intermittent Fasting Meal Replacement Diet and ... In this randomized clinical trial of 405 adults, the 5:2 MR approach achieved better glycemic control at 16 weeks compared with metformin and empagliflozin.

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1325894/full

The effects of different intermittent fasting regimens in ... The SUCRA results showed that patients with T2DM on TWF had the best combined effect in improving fasting glucose and insulin resistance ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2451847618300290

The safety and efficacy of weight loss via intermittent ... These findings suggest that both intermittent fasting or continuous energy restriction are safe and effective weight loss approaches for people with type 1 ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2688344

Effect of Intermittent Compared With Continuous Energy ... Intermittent energy restriction is safe for people who have either diet-controlled type 2 diabetes or are using medication that is not likely to ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1043276024000213

Review Clinical potential of fasting in type 1 diabetes This review examines the efficacy of TRE and other fasting protocols in improving weight and glycemic control in patients with obesity and T1DM.