Clinical Research Directory

Effects of Semaglutide in HIV-Associated Lipohypertrophy

This is a randomized, double-blinded, placebo-controlled trial designed to assess the effect of the GLP-1 receptor agonist, semaglutide, on visceral and ectopic fat, insulin resistance, inflammation markers, and the downstream effect of cardiovascular risk in people with HIV. The primary endpoints will be visceral and ectopic fat changes over the study period. The secondary endpoints will include changes in markers of inflammation, immune activation, gut integrity, and cardiovascular disease risk assessment.

Innovative Insulin Injection Sites Map to Minimize Lipohypertrophy Risk

Background: Patients on long-term insulin therapy frequently develop a condition called lipohypertrophy (LH), which involves the accumulation of abnormal fatty tissue at insulin injection sites. This condition is caused by repeated injections in the same area and can lead to inconsistent insulin absorption, unpredictable blood sugar levels, and increased risks of hypoglycemia and hyperglycemia. While standard care often includes verbal instructions on site rotation, many patients continue to struggle with technique and develop these complications. Study Purpose: This study aims to evaluate the effectiveness of a novel "Insulin Injection Sites Map" (provided in either digital or physical format) compared to standard verbal care. The study seeks to determine if this structured, visual mapping tool helps patients better manage their injection rotation, reduces the occurrence and severity of lipohypertrophy, and ultimately improves glycemic control (as measured by HbA1c and fasting blood glucose). Study Design: This is a prospective, randomized controlled trial (RCT) conducted at the outpatient medical clinic of Matrouh General Hospital. The study includes adult participants (aged 18 and older) diagnosed with Type 1 or Type 2 diabetes who have been using insulin therapy for at least six months. Participants are divided into two groups: Intervention Group: Patients who receive the novel structured insulin injection sites map and instructions on systematic rotation. Control Group: Patients who receive routine care, consisting of standard verbal instructions on site rotation without visual mapping aids. Outcome Measures: Over a six-month follow-up period, the study monitors and compares both groups on the following key metrics: Incidence and Severity of Lipohypertrophy: Evaluated through physical inspection and palpation of injection sites for lumps, firmness, or tenderness. Adherence to Rotation Protocols: Measured using patient logs and site rotation scores to determine if participants are following the recommended rotation sequence. Glycemic Control: Tracked through clinical monitoring of HbA1c percentages and fasting blood glucose levels to assess the impact of better injection technique on overall diabetes management.

Glucose Variability in Subclinical Hypertrophy

Evaluation of insulin absorption at sites affected by clinically apparent lipohypertrophy through short-term continuous glucose monitoring has shown inconsistent results and it is yet unknown how or if subclinical lipohypertrophy affects absorption. In this study investigators propose to enroll at least 20 people who participated in phase 1 and who were determined to have subclinical lipohypertrophy to examine the correlation between glycemic control and amount of insulin injected in subclinical hypertrophic areas using capillary blood glucose and continuous glucose monitoring.

The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

Lipohypertrophy is swelling of the fatty tissue located below the skin ("subcutaneous tissue") where many patients with diabetes inject their insulin. Lipohypertrophy can sometimes be felt as firm swelling, lumps or small bumps near insulin injection sites. Previous studies have shown that injecting insulin into areas of lipohypertrophy can affect how insulin is absorbed, and can increase insulin requirements in patients. New data suggest that lipohypertrophy can be detected using ultrasound technology. The ultrasonographic presence of changes to the subcutaneous tissue without swelling that can be felt ("subclinical lipohypertrophy") and the effect of injecting insulin into these sites is unknown. 100 people will participate in the Phase 1 of this study. In the second phase of the study, 40 patients identified with subclinical lipohypertrophy in Phase 1 will be asked to participate in the randomized study using crossover design by checking your glucose levels.