Study of Arginine and Nitric Oxide in Patients With Diabetes

NCT03566524 | Completed

• 1 other identifier: DK101411
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the effect of citrulline versus placebo supplementation in ketosis-prone diabetes (KPD) patients on arginine and nitric oxide production and on glucose- and arginine-stimulated insulin secretion and arterial flow-mediated dilation.

Conditions

Ketosis Prone Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Arginine production

  The change in the amount of arginine produced from baseline in response to supplements of citrulline versus alanine (placebo) will be assessed by stable isotope tracers after 3 weeks of supplementation.

  Three weeks

Secondary Outcomes (3)

• Change in Nitric Oxide Synthesis

  Three weeks

• Change in Arterial function

  Three weeks

• Change in Insulin secretion

  Three weeks

Study Arms (2)

Citrulline

EXPERIMENTAL

In this arm, 10 ketosis prone diabetes patients will be randomly assigned to receive 34.2 mmol/d of dietary citrulline for 20 days. Citrulline will be in the form of 2.85 mmol capsules and patients will be instructed to consume 4 capsules with each of their 3 main meals. The citrulline will be provided in a double-blind fashion by a designated unblinded investigator who will not come in direct contact with the subjects.

Dietary Supplement: Citrulline

alanine

PLACEBO COMPARATOR

In this arm, 10 ketosis prone diabetes patients will be randomly assigned to receive 34.2 mmol/d of dietary alanine for 20 days. Alanine will be in the form of 2.85 mmol capsules and patients will be instructed to consume 4 capsules with each of their 3 main meals. The alanine will be provided in a double-blind fashion by a designated unblinded investigator who will not come in direct contact with the subjects.

Dietary Supplement: Alanine

Interventions

Citrulline DIETARY_SUPPLEMENT

Ketosis prone diabetes patients (n=10) will be randomly assigned to receive either dietary supplement of citrulline or alanine as placebo. They will then cross over to the other supplement.

Citrulline

Alanine DIETARY_SUPPLEMENT

Ketosis prone diabetes patients (n=10) will be randomly assigned to receive either dietary supplement of citrulline or alanine as placebo. They will then cross over to the other supplement.

alanine

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New onset (defined as receiving a diagnosis within the past 1 year) diagnosis of unprovoked" A-β+ ketosis-prone diabetes
• Aged 20-65 years
• In good health except for diabetes without clinical evidence of micro- or macrovascular complications by history, physical exam and blood chemistries

You may not qualify if:

• Chronic or acute illness
• History of myocardial infarction or coronary artery disease or stroke,
• Renal insufficiency (eGFR \<90mL/min/1.73m2; \<30 mg albumin / g creatinine in urine)
• Abnormal liver, thyroid, gonadal or adrenal functions
• On medications other than metformin,
• On any hormonal replacement therapy
• Pregnancy

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor St Lukes Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Citrulline; Alanine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 25, 2018
• Study Start: July 1, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)