Clinical Trials Logo

Clinical Trial Summary

The pharmacological approaches in the treatment of type 2 diabetes (T2DM) have advanced radically during the last decades. However, focus on long-term management of body weight, which is an essential part of treatment success, is often lacking. Excluding surgery, there are only a few effective treatment methods for obesity. Management of obesity is also greatly challenged by weight regain, which is common after a successful lifestyle intervention. Weight regain typically results in the deterioration of glucose homeostasis in T2DM. However, understanding the pathomechanisms of weight regain and subsequent worsening of glucose homeostasis is still insufficient. Therefore, T2DM treatment programs that target long-term weight management have been scarce. This study aims to fill the gaps in the current knowledge by advancing the development of treatment programs for T2DM that simultaneously head for improved glucose metabolism and improved long-term body weight control.

Clinical Trial Description

In this randomized, double-blind, parallel, placebo-controlled trial we compare the effects of semaglutide 1.34 mg/ml vs. normal dieting by randomizing the patients with both T2DM and overweight/obesity (BMI ≥27) (n=50, aged ≥18 to < 65 years) to two groups: both groups participate in a similar lifestyle treatment to induce weight loss, but one group gets an add-on of semaglutide 1.34mg/ml while the other is treated with placebo. Additionally, a reference group of healthy normal weight non-diabetic individuals (BMI ≤ 25 kg/m2, n=25, aged ≥18 to < 65 years) are included as controls at the initiation of the study. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04854083
Study type Interventional
Source Helsinki University Central Hospital
Contact Kirsi H Pietiläinen, MD PhD
Phone +358505992295
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date May 2021
Completion date August 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03239366 - A Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes Population Phase 2
Recruiting NCT04597229 - Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus N/A
Recruiting NCT03623139 - Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes N/A
Recruiting NCT04511325 - Effects of White Potato Consumption on Measures of Cardiometabolic Health in Individuals With Type 2 Diabetes Mellitus N/A
Recruiting NCT04599920 - Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life) N/A
Active, not recruiting NCT03422471 - Hypoglycemia and Autonomic Nervous System Function- B2 N/A
Recruiting NCT04382521 - A Text Message Intervention to Promote Health Behaviors in Cardiac Risk Conditions N/A
Recruiting NCT04564391 - Whey or Casein - Liver Fat Reduction and Metabolic Improvement by Fast vs. Slow Proteins N/A
Recruiting NCT03458715 - The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin Phase 4
Terminated NCT03278236 - Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men? N/A
Completed NCT02974504 - Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN) Phase 4
Not yet recruiting NCT03659383 - The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine Phase 4
Completed NCT03542240 - Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome N/A
Completed NCT03657537 - Effects of Ketone Bodies on Cognition in Type 2 Diabetes Phase 1
Completed NCT03979768 - Risk Assessment of Type 2 Diabetes in Pharmacies N/A
Completed NCT03614039 - Effect of Probiotic and Smectite Gel on NAFLD N/A
Active, not recruiting NCT03290768 - Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3) N/A
Recruiting NCT04088851 - "The Role of the Liver for Interorgan Metabolic Crosstalk in Type 2 Diabetes" N/A
Completed NCT03643783 - Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients
Recruiting NCT03423108 - Exercise Dose-response for Diabetes in the Elderly N/A