USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-92-246

Project Title:

Body Composition of Diabetic Patients with Hyperkalemia

Principle Investigator: Dr. Ruimei Ma

Project started in: 1992

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-Federal: St. Luke's Roosevelt Hospital

Amount: $26,000 (Est.)
Comments:

Funding is a subcontract from St. Luke's Roosevelt Hospital, whose research is funded by National Institute of Diabetes and Digestive and Kidney Disease (NIDDK).

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: December 07, 1994

Number of Human Subjects in the Last Reporting Period for this Project: 12
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For clinical research.

Internal administration of radioactive substances to human subjects.

• For clinical research.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The general objective of this study is to understand better the pathogenesis, significance and effects of treatment of hyperkalemia in patients with advance Type II diabetes mellitus (IIDM). Specifically, it will attempt to relate hyperkalemia and treatment (diuresis) directed toward its normalization to changes in body composition, e.g., total body potassium by whole body counting of natural K-40; total body nitrogen by prompt gamma neutron activation, total body sodium, total body calcium and total body chloride by delayed gamma neutron activation; and total body water by isotope dilution of tritiated water. A total of 40 subjects will be studied over a period of two years. Approximately half of these will be patients with IIDM and half will be control subjects. Half of the subjects will be studied twice (once before and once after diuretic therapy). Elemental body compositions will be determined by whole body counting, in vivo neutron activation analysis and tritiated water dilution method. Subjects will be exposed to ionizing radiation including neutrons, gamma-rays and electrons. Subjects will be given tritiated water by mouth. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.