Skip to main content
OpenTrials
Completed

NCT Number: NCT01135186

Impact of KUVAN® on Gastric Relaxation in Women With Diabetic Gastroparesis.

Kuvan® (sapropterin dihydrochloride) for Improving Gastric Accommodation in Women with Diabetic Gastroparesis (KIGA-DG)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

Patients are invited to participate in a research study of Kuvan® (sapropterin dihydrochloride). We hope to learn whether treatment with Kuvan® is safe and effective in improving the ability of the stomach to relax after eating and improving the symptoms of diabetic gastroparesis. Women are selected as a possible participant in this study because they have diabetes and moderate to severe gastroparesis (meaning stomach empties slowly).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion Criteria

Patients with moderate to severe symptoms of diabetic gastroparesis will be studied (GCSI >21). Patients should not have post-surgical gastroparesis or dyspeptic symptoms with normal gastric emptying. In order to qualify for inclusion in the trial, patients must satisfy the following inclusion criteria:

  • Diagnosis of diabetes mellitus > 5 years requiring medical therapy
  • Female gender
  • Ages 18-65 years
  • Documentation of delayed gastric emptying on gastric emptying scintigraphy (within 2 years of enrollment)
  • Symptoms of gastroparesis for at least 6 months with Gastroparesis Cardinal Symptom Index (GCSI) score > 21 indicating moderate to severe symptoms
  • Recent negative upper endoscopy or upper GI series within 2 years of enrollment (no evidence of mechanical obstruction or peptic ulcer disease)

Exclusion criteria

Exclusion Criteria

Patients who satisfy any of the following exclusion criteria will be ineligible for enrollment in the study:

  • Diabetes diagnosed < 5 years prior to the study
  • Male gender
  • Normal gastric emptying
  • Gastroparesis from post-surgical etiologies
  • Another active disorder, which could explain symptoms in the opinion of the investigator
  • Pregnancy
  • History of significant cardiac arrhythmias and/or prolonged QTc
  • Daily use of narcotic analgesics for abdominal pain
  • Contraindications to gastric emptying breath test: patients with a known allergy to egg, wheat, or algae.
  • Underlying seizure disorder
  • Known history of cardiac ischemia
  • Recent clinically significant gastrointestinal bleeding
  • Patients taking Levodopa
  • Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
  • Failure to give informed consent
  • Surgery for placement of a gastric stimulator within the past 6 months (patients > 6 months post-op with persistent symptoms and delayed gastric emptying are eligible).
  • A normal upper endoscopy not performed within 2 year of study entry.
  • Patients taking phosphodiesterase inhibitors such as sildenafil, vardenafil, tadalafil
  • Patients with renal impairment (i.e. Creatinine > 2.5 mg/dL)
  • Patients with hepatic dysfunction (i.e. ALT and AST values > 2.5x ULN and T. bilirubin > 1.5x ULN)
  • Patients with uncontrolled diabetes, such as HbA1c > 10 mg/dl at screening/baseline will be excluded.

Treatment and study plan

Sapropterin Dihydrochloride

Drug

sapropterin dihydrochloride: 10mg/kg/day

Other names: KUVAN

Primary outcomes

  1. Gastric Accommodation

    Time frame: Baseline, 4 Weeks, 8 Weeks

    Gastric Accommodation refers to the reflexive relaxation of the upper stomach after swallowing as measured by the Satiety Test at baseline, 4 weeks, and 8 weeks.

    Increased gastric accommodation is considered a positive outcome.

Secondary outcomes

  1. Secondary Outcome Measures Will Include Change in Symptom Severity.

    Time frame: Baseline, 4 Weeks, 8 Weeks

    Change in symptom severity over the past 2 weeks as measured by the patient reported Gastroparesis Cardinal Symptom Index (GCSI)

    The GCSI is composed of 9 questions.

    Each question asks about symptom severity on a scale of 1-5 listed below.

    0=None 1= Very mild 2= Mild 3=Moderate 4=Severe 5= Very severe

    The 9 scores are summed together for cumulative GCSI score. The minimum cumulative score is '"0" and the maximum cumulative score is "45."

    Once we calculated the cumulative score for each participant, we took the average of all participants cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.

    Higher total scores indicate higher symptom severity. Lower total scores indicate lower symptom severity.

  2. Secondary Outcome Measures Will Include Change in Quality of Life.

    Time frame: Baseline, 4 Weeks, 8 Weeks

    Quality of life as impacted by patients with upper gastrointestinal disorders (PAGI-QOL)

    The PAGI-QOl is composed of 30 questions.

    Each question asks about the degree to which a patient's quality of life is impacted by upper gastrointestinal disorders.

    Questions measure quality of life impact on a scale of 1-5 listed below.

    0=none of the time, 1=a little of the time, 2=some of the time, 3=a good bit of the time, 4= most of the time, 5= all of time

    The 30 items are summed together for a cumulative PAGI-QOL score. The minimum cumulative score is "0" and the maximum score is "150."

    Once we calculated the cumulative score for each participant, we took the average of all participants cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.

    Lower scores indicate an improved overall quality of life. Higher scores indicate a diminished overall quality of life.

  3. Secondary Outcome Measures Will Include Change in Symptom Severity as Measured by the Patient Assessment of Gastrointestinal Disorder-Symptom Severity Index Disorders Symptom Severity Index (PAGI-SYM)

    Time frame: Baseline, 4 Weeks, 8 Weeks

    Symptom severity as measured by the Patient Assessment of Upper Gastrointestinal Disorder- Symptom Severity Index. (PAGI-SYM)

    The PAGI-SYM is compose of 20 questions.

    Each question can be answered on a scale of 1-5 (below)

    0 = none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe

    Cumulative scores were calculated by summing all 20 questions.

    The minimum cumulative scores would be "0" while the maximum cumulative score would be "100"

    Once we calculated the cumulative score for each participant, we took the average of all the cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.

    Lower score indicates decreased symptom severity. Higher score indicates increased symptom severity.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Kuvan® (Sapropterin Dihydrochloride) for Improving Gastric Accommodation in Women With Diabetic Gastroparesis (KIGA-DG)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2010
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.