Glucose and Amino Acids for High Blood Sugar

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must be taking: Sulfonylureas, Metformin

Must not be taking: Insulin, Glucose-lowering agents

Disqualifiers: Pregnancy, Abdominal surgery, Systemic illness, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 240 minutes

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how amino acids and glucose influence the release of hormones like insulin and glucagon, which are vital for blood sugar control. Participants will receive either an infusion of glucose (dextrose) alone or glucose with amino acids (such as Clinisol 15%) to observe the different effects. The trial seeks healthy adults, obese adults, and adults with type 2 diabetes who manage their condition with metformin or sulfonylureas. Those with type 2 diabetes not using insulin, or those who are obese without diabetes, might be suitable candidates. The trial aims to enhance understanding of better treatments for managing blood sugar levels in various health situations. As a Phase 4 trial, the treatment has already received FDA approval and proven effective. This research seeks to understand how it benefits more patients, offering participants a chance to contribute to advancements in diabetes care.

Will I have to stop taking my current medications?

If you have type 2 diabetes, you can continue taking sulfonylureas or metformin. However, if you are obese without diabetes or lean without diabetes, you cannot use any glucose-lowering medications, including metformin or sulfonylureas.

What is the safety track record for Clinisol 15% and Dextrose?

Research has shown that Clinisol 15% and dextrose are generally well-tolerated. Clinisol 15%, an amino acid injection, helps balance nitrogen in the body. Some issues, such as changes in metabolism, have been reported, but these usually occur with long-term use. Short-term use in studies has not shown serious problems.

Dextrose, also known as glucose, treats low blood sugar. It is usually well-tolerated and quickly raises blood sugar levels. However, very high or low blood sugar levels can be dangerous if not managed properly.

This study is in Phase 4, indicating that these treatments have already been approved and are considered safe for general use. This phase focuses on understanding specific effects and improving their use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they explore the potential of combining glucose with amino acids to manage high blood sugar levels differently than existing options. Most treatments for high blood sugar, such as metformin or insulin injections, focus on either increasing insulin sensitivity or providing insulin directly. However, this trial is investigating how an amino acid mixture, Clinisol 15%, infused with glucose, might impact blood sugar levels. This approach could offer a new way to stabilize blood sugar, especially for those with type 2 diabetes, by potentially aiding the body's natural metabolism differently than current medications. This could open up new avenues for managing blood sugar with a unique combination therapy.

What evidence suggests that this trial's treatments could be effective for high blood sugar?

Research has shown that mixing Clinisol 15% (a blend of amino acids) with dextrose (a type of sugar) might help the body use amino acids more effectively and manage blood sugar levels. In this trial, one group of participants will receive an IV infusion of glucose alone, while another group will receive an IV infusion of glucose combined with Clinisol 15%. Studies have found that amino acids can affect the release of hormones like insulin, which helps control blood sugar. While dextrose alone can quickly raise blood sugar, adding amino acids might change how the body reacts to this increase. Early results suggest this combination could help manage high blood sugar by balancing hormone release. This approach shows promise for people who have trouble controlling their blood sugar, such as those with type 2 diabetes. ^{4 5 6 7 8}

Who Is on the Research Team?

Adrian Vella, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people with high blood sugar, obesity, or type 2 diabetes. Diabetic participants need an HbA1c level below 8.5%, while obese and lean individuals must have it under 6.5%. Obese subjects should have a BMI of at least 28, and lean ones a BMI up to 25. Only diabetics on sulfonylureas or metformin can join, and women must not be pregnant. Those with major surgeries, active illnesses like cancer, severe vascular diseases, or who can't undergo MRI are excluded.

Inclusion Criteria

No contraindications to MRI (e.g., metal implants, claustrophobia).

I only use sulfonylureas or metformin for my type 2 diabetes.

HbA1c ≤ 6.5% (obese and lean subjects).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an IV infusion of glucose and either saline or amino acids, with frequent blood draws to monitor blood glucose levels

240 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinisol 15%
• Dextrose

Trial Overview

The study tests how amino acids (using Clinisol) affect glucagon and insulin release compared to glucose alone (using Dextrose). It aims to understand these effects in healthy individuals as well as those with obesity or type 2 diabetes.

How Is the Trial Designed?

Group I: Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Saline and Glucose Experimental Treatment 1 Intervention

Study visit: Subjects will receive a caffeine free, standardized evening meal and remain fasting overnight. An IV infusion of saline and glucose (50%) will be given the next morning and continue until the end of study. Blood draws will be collected frequently from the IV line to monitor blood glucose levels.

Group II: Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Amino Acid and Glucose Experimental Treatment 2 Interventions

Study visit: Subjects will receive a caffeine free, standardized evening meal and remain fasting overnight. An IV infusion of glucose (50%) will be given the next morning together with an IV infusion of Clinisol 15% (an amino acid mixture) will be given the next morning and continue until the end of study. Blood draws will be collected frequently from the IV line to monitor blood glucose levels.

Clinisol 15% is already approved in United States for the following indications:

Approved in United States as Clinisol SF for:

• Nutrition support for patients requiring parenteral nutrition (PN) when oral or enteral intake is not possible, insufficient, or contraindicated
• Treatment of negative nitrogen balance in patients where the alimentary tract cannot or should not be used, gastrointestinal absorption of protein is impaired, or metabolic requirements for protein are substantially increased, as with extensive burns

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study of premature infants weighing under 1500 g, alternating intravenous administration of hypertonic glucose and Aminosol-glucose led to increased plasma insulin and growth hormone levels, but did not improve nitrogen utilization from amino acids, with over 50% of administered nitrogen being excreted.

The hormonal responses to the glucose and amino acid infusions did not prevent metabolic acidosis, which was variable but generally compensated, indicating that while the treatment altered hormone levels, it did not effectively enhance the metabolic benefits expected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic and hormonal effects of alternate infusion of hypertonic glucose and aminosol-glucose in premature infants. Rubecz, I., Mestyán, J., Soltész, G., et al.[2013]

The experimental solution P900, when combined with 5 mg of cortisol/liter, can be safely infused through peripheral veins for extended periods (average 114 hours) and improves nutritional balances in undernourished subjects, preventing negative balances of nitrogen, phosphorus, magnesium, and potassium.

P900 with cortisol, along with a daily oral intake of 670-1700 calories, provides nutritional benefits comparable to the concentrated hyperalimentation solution C1,800, indicating its potential as an effective alternative for nutritional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenteral nutrition of adults with a 900 milliosmolar solution via peripheral veins. Isaacs, JW., Millikan, WJ., Stackhouse, J., et al.[2018]

Ingesting leucine and glycine together with glucose significantly reduced the glucose response by 66% and increased insulin levels by 24% compared to glucose alone, indicating a beneficial effect on blood sugar control.

However, the combined effect of leucine and glycine on glucose response was not additive compared to their individual effects, suggesting a complex interaction that requires further investigation to understand the underlying mechanism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction of ingested leucine with glycine on insulin and glucose concentrations. Iverson, JF., Gannon, MC., Nuttall, FQ.[2021]

Enamine derivatives, particularly sodium DL-phenylalanate, significantly enhance the rectal absorption of insulin in normal rabbits, suggesting a potential method for improving insulin delivery.

In diabetic rabbits, insulin formulations containing these enamines effectively lowered serum glucose levels to normal for over 2.5 hours, with gelatin microenemas showing superior insulin absorption compared to traditional suppositories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of enamine derivatives on the rectal absorption of insulin in dogs and rabbits. Kim, S., Kamada, A., Higuchi, T., et al.[2019]

In a study of 68 neonates requiring parenteral nutrition, those treated with Vamin 9 glucose had a higher mortality rate, especially in infants weighing 1000 grams or more, compared to those receiving MB233G.

The MB233G preparation was found to maintain plasma amino acid levels within the normal range for newborns, while Vamin 9 glucose led to significantly elevated levels of certain amino acids, indicating potential safety concerns with Vamin 9 glucose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical trial of two parenteral nutrition solutions in neonates. McIntosh, N., Mitchell, V.[2019]

Citations

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Anticipating drug effects on blood glucose levels helps maintain control. Table 15 lists some medications, which are known to affect blood glucose levels.

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The amino acid intervention is provided in addition to 'usual care' enteral and/or parenteral nutrition via an intravenous infusion (Clinisol 15% by Baxter) to ...

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The following metabolic complications have been reported with administration of TPN: metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, ...

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Safety and effectiveness of 15% CLINISOL - sulfite-free (Amino Acid) Injection in pediatric patients have not been established by adequate ...

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This medicine may contain aluminum. There is a chance of aluminum toxicity if you are on Aminosyn II (amino acid injection) for a long time. The ...