Kristina Ingeborg Rother, M.D., M.H.Sc.

Clinical Trials

Open studies conducted by NIDDK Principal Investigators appear below. Study statuses may include the following:

  • Open: Recruiting - Currently recruiting participants and open to everyone who meets eligibility criteria.
  • Open: Active, Not Recruiting - Participants are receiving an intervention or being examined, however new participants are not being recruited or enrolled.
  • Open: Enrolling by Invitation - People in a particular population were selected in advance and invited to participate. The study is not open to everyone who meets the eligibility criteria.
  • Open: Available for Expanded Access - Patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.

Studies Seeking Patients

Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)

Background: Artificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes. Objective: To see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized. Eligibility: People ages 18-60 who: - Are black or Hispanic - Weigh more than 110 pounds - Have a body mass index of 25-40 - Do not have a condition that requires drug treatment Design: Participants will be screened with: - Medical history - Physical exam - Blood, heart, and urine tests Participants must not eat or drink anything with artificial sweeteners throughout the study. Over 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study. Overnight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes: - An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours. - A piece of fat tissue may be taken from the abdomen (biopsy). - Participants will have a sweet drink. Blood samples will be taken over 2 hours. Then participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries. Overnight Visit 2 repeats Visit 1 except the biopsy. Then participants will take the capsules for another 2 weeks. Overnight Visit 3 repeats Visit 1. Participants may be contacted by phone within 4 weeks after they finish.

The trial is Open with a status of Recruiting.

Investigator: Kristina I Rother, M.D.

Referral Contacts: Email: Ellen Conway Phone: (301) 594-0601

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Metabolic Effects of Non-Nutritive Sweeteners

Background: - Artificial sweeteners, such as sucralose (brand name Splenda), are very commonly found in products such as diet soft drinks. Recently, researchers learned that these sweeteners may affect hormones in the body, especially when they are consumed in combination with real sugar. Changes in hormone levels may, in turn, result in changes in blood sugar, appetite, and weight. Researchers are interested in studying the effects of artificial sweeteners on the metabolism and hormonal levels of healthy volunteers. Objectives: - To study the effects that artificial sweeteners have on hormone levels, blood sugar, and appetite. - To evaluate whether artificial sweeteners change the rate at which food passes out of the stomach into the gut, or the rate at which the body absorbs sugar from the gut. - To evaluate the effects that different amounts of artificial sweeteners have on hormone levels. Eligibility: - Healthy volunteers between 18 and 45 years of age. Design: - This study will require one screening visit and four testing visits, scheduled on different days. - At the screening visit, eligible participants will be screened with a physical examination, medical history, blood samples, and body measurements (including height, weight, body circumferences, and skin folds). Participants will also be asked about how much artificial sweetener they typically consume and will have taste tests, in which a small amount of flavored liquid is placed on the tongue and participants will name the flavor and rate its intensity. - Participants will have four glucose tolerance tests on four different days. In preparation for the test, participants will not eat or drink anything but water for 12 hours prior to the test. Blood will be drawn before the test, and participants will drink one of the following study liquids, selected at random: - Plain water - Water mixed with sucralose (the amount found in one 12 oz diet soft drink) - Water mixed with sucralose (the amount found in 2.5 12 oz diet soft drinks) - Water mixed with sucralose (the amount found in 3.7 12 oz diet soft drinks) - Ten minutes after drinking the study liquid, participants will have a sugary drink that will allow researchers to measure sugar absorption and the speed with which food leaves the stomach. - In addition, participants will complete questionnaires about hunger levels before drinking the sugar solution and at regular intervals for 2 hours afterward. Blood samples will be taken at regular intervals as well.

The trial is Open with a status of Recruiting.

Investigator: Kristina I Rother, M.D.

Referral Contacts: Email: Brianna C Halasa Phone: (301) 402-2486

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