R-5280 (HAMS-AB) for Type 1 Diabetes

(R-5280 Trial)

Recruiting at 4 trial locations

Overseen By Christian Freguia, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Rise Therapeutics LLC

Must not be taking: Steroids, Immunosuppressants, Antibiotics, others

Disqualifiers: Type 2 diabetes, Pregnancy, Celiac, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

39 Participants Needed

Trial Summary

What is the purpose of this trial?

Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

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

The trial protocol does not specify if you need to stop your current medications, but it does exclude those who have used steroids or other immunosuppressants in the past six months.

Is HAMS-AB safe for humans?

A study on HAMS-AB, a modified form of high amylose maize starch, showed it prevented type 1 diabetes in rodents without any safety issues, suggesting it may be safe for humans. ^{1 2 3 4 5}

How is the treatment HAMS-AB unique for type 1 diabetes?

HAMS-AB is unique because it is a modified resistant starch that increases the production of short-chain fatty acids (SCFAs) in the gut, which have anti-inflammatory effects and can improve insulin sensitivity and secretion. This approach targets the gut microbiome to potentially prevent or manage type 1 diabetes, unlike traditional treatments that focus directly on insulin regulation. ^{4 5 6 7 8}

What data supports the effectiveness of the treatment HAMS-AB for Type 1 Diabetes?

Research shows that HAMS-AB, a modified form of high amylose maize starch, increases the production of short-chain fatty acids (SCFAs) in the gut, which have anti-inflammatory effects and can improve blood sugar control. In a rodent model, HAMS-AB prevented Type 1 Diabetes without adverse effects, suggesting potential benefits for managing the condition in humans. ^{2 5 6 9 10}

Eligibility Criteria

This trial is for children aged 11-17 recently diagnosed with Type 1 Diabetes, who are not overweight and willing to follow a healthy diabetic diet. They can't have other forms of diabetes, ongoing infections or recent antibiotic use, compromised immunity, steroid or immunosuppressant use in the last six months, be pregnant, on high-fiber/vegetarian diets or have certain allergies.

Inclusion Criteria

You weigh less than 85% of what is considered healthy for your height.

I was diagnosed with Type 1 Diabetes within the last 2 years.

I am a child aged 11-17 years newly diagnosed with the condition.

Exclusion Criteria

You are allergic to corn, milk, or soy or any products made from them.

Participation in other intervention research trials within the past three (3) months

I have a genetic form of diabetes or type 2 diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive R-5280 or placebo, taken twice a day orally with food for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HAMS-AB

Trial Overview The study tests R-5280's safety and how well it works in kids newly diagnosed with Type 1 Diabetes compared to a placebo. It aims to see if R-5280 can help manage their condition better.

Participant Groups

Group I: Active Comparator Active Control 1 Intervention

R-5280, Taken Twice a day, orally with food for 12 weeks (84 days)

Group II: Placebo Comparator Placebo Group 1 Intervention

Food starch, taken twice a day, orally with food for 12 weeks (84 days)

Who Is Running the Clinical Trial?

Rise Therapeutics LLC

Lead Sponsor

Trials

5

Recruited

180+

Findings from Research

A modified high amylose starch (mHAS) was identified as a potential carbohydrate source for sterilized liquid products that can maintain a low glycemic index, which is beneficial for diabetics.

In tests with male Wistar rats, the heat-treated mHAS solution significantly reduced postprandial plasma glucose and insulin responses compared to maltodextrin, suggesting it may help manage blood sugar levels effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sterilization in a liquid of a specific starch makes it slowly digestible in vitro and low glycemic in rats. Severijnen, C., Abrahamse, E., van der Beek, EM., et al.[2023]

In a pilot study involving 21 patients with glycogen storage diseases, the new starch WMHM20 provided better short-term metabolic control than uncooked cornstarch, with a longer duration of stable blood glucose levels.

Patients experienced a slower decrease in glucose levels and a faster suppression of lactate when using WMHM20, indicating its potential for improved management of metabolic responses in GSDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel starch for the treatment of glycogen storage diseases. Bhattacharya, K., Orton, RC., Qi, X., et al.[2019]

A pilot study involving 12 newly diagnosed youth with type 1 diabetes will assess the effects of high amylose maize starch (HAMS-AB) on gut microbiome changes, short chain fatty acid production, and β cell health, aiming to improve glycemia and immune responses.

Previous research indicates that HAMS-AB can prevent type 1 diabetes in rodent models without safety concerns, suggesting it may be a safe and effective dietary intervention for enhancing metabolic health in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effect of prebiotics on the gut microbiome profile and β cell function in youth with newly diagnosed type 1 diabetes: protocol of a pilot randomized controlled trial. Ismail, HM., Spall, M., Evans-Molina, C., et al.[2023]

A 6-week trial of a dietary supplement containing high-amylose maize-resistant starch modified with acetate and butyrate (HAMSAB) in adults with long-standing type 1 diabetes (T1D) showed increased levels of beneficial short-chain fatty acids (SCFAs) in stools and plasma, indicating a positive shift in gut microbiota composition.

While the supplement did not change glucose control or insulin requirements overall, participants with the highest SCFA levels experienced better glycemic control, suggesting that targeting dietary SCFAs could help improve immune profiles and promote better management of T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolite-based dietary supplementation in human type 1 diabetes is associated with microbiota and immune modulation. Bell, KJ., Saad, S., Tillett, BJ., et al.[2022]

In a study involving 51 participants with type 1 diabetes, consuming 5 g of uncooked cornstarch as an evening snack significantly reduced the incidence of nocturnal hypoglycemia compared to a standard snack, with hypoglycemia episodes dropping from 30 to 6 at midnight (P < 0.001).

The use of uncooked cornstarch did not lead to an increase in hyperglycemic events, indicating it is a safe option for preventing nighttime low blood sugar without causing high blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, blinded trial of uncooked cornstarch to diminish nocturnal hypoglycemia at diabetes camp. Kaufman, FR., Halvorson, M., Kaufman, ND.[2019]

In a study involving 18 participants (12 with diabetes and 6 nondiabetic), hydrogenated starch hydrolysates (HSHs) produced a lower post-meal glycemic response compared to glucose, indicating they may be a better option for managing blood sugar levels.

Among the HSHs tested, HSH 6075 resulted in a higher glycemic response than HSH 5875, suggesting that the type of HSH can influence carbohydrate absorption and glycemic impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic response to oral challenge of hydrogenated starch hydrolysate versus glucose in diabetes. Wheeler, ML., Fineberg, SE., Gibson, R., et al.[2019]

In a study involving 20 infants and 21 toddlers with chronic diarrhea, the modified starch acetylated distarch phosphate (ADiSP) was found to increase breath hydrogen levels and cause loose stools in some cases, indicating potential malabsorption issues.

The addition of sorbitol and fructose to modified starch formulas exacerbated these malabsorption effects, leading to increased breath hydrogen and diarrhea in both infants and toddlers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malabsorption of modified food starch (acetylated distarch phosphate) in normal infants and in 8-24-month-old toddlers with non-specific diarrhea, as influenced by sorbitol and fructose. Lebenthal-Bendor, Y., Theuer, RC., Lebenthal, A., et al.[2019]

A study by Bell et al. indicates that dietary supplementation with modified resistant starch fiber can change immunotolerance in individuals with type 1 diabetes.

This research suggests a potential new dietary approach to managing immune responses in type 1 diabetes, although further details on the study's methods and participant numbers are needed for a complete understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbial influencers: treating diabetes through the gut. Snelson, M., Rampanelli, E., Nieuwdorp, M., et al.[2022]

An 82-year-old man with autoimmune hypoglycemia was successfully treated with hydrothermally modified slow release corn starch, achieving stable blood sugar levels after dietary restrictions failed.

This treatment is easy to administer, well tolerated, and offers a non-invasive option for managing hypoglycemia in patients who do not respond adequately to diet alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrothermally modified slow release corn starch: a potential new therapeutic option for treating hypoglycemia in autoimmune hypoglycemia (Hirata's disease). Lechner, K., Aulinger, B., Brand, S., et al.[2018]

In a study involving three patients with type I and III glycogenosis, administering raw corn starch at night effectively maintained normal blood sugar levels and prevented lactic acidosis for several hours after ingestion.

After one year of treatment with raw corn starch, all patients showed improved metabolic control, including stable morning blood sugar levels, reduced liver enlargement, and increased growth rates in two cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Corn starch in the treatment of patients with glycogenosis type I and III]. Galiano Segovia, MJ., Moreno Villares, JM., Medina Benítez, E., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sterilization in a liquid of a specific starch makes it slowly digestible in vitro and low glycemic in rats. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A novel starch for the treatment of glycogen storage diseases. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Evaluating the effect of prebiotics on the gut microbiome profile and β cell function in youth with newly diagnosed type 1 diabetes: protocol of a pilot randomized controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Metabolite-based dietary supplementation in human type 1 diabetes is associated with microbiota and immune modulation. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

A randomized, blinded trial of uncooked cornstarch to diminish nocturnal hypoglycemia at diabetes camp. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Metabolic response to oral challenge of hydrogenated starch hydrolysate versus glucose in diabetes. [2019]

7. Norway pubmed.ncbi.nlm.nih.gov

Malabsorption of modified food starch (acetylated distarch phosphate) in normal infants and in 8-24-month-old toddlers with non-specific diarrhea, as influenced by sorbitol and fructose. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Microbial influencers: treating diabetes through the gut. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Hydrothermally modified slow release corn starch: a potential new therapeutic option for treating hypoglycemia in autoimmune hypoglycemia (Hirata's disease). [2018]

10. Spain pubmed.ncbi.nlm.nih.gov

[Corn starch in the treatment of patients with glycogenosis type I and III]. [2013]