Clinical trial

The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction

Name

22-000233

Description

Caloric restriction (and RYGB) improves insulin action and lowers fasting glucose, glucagon and EGP, without changes in postprandial EGP and glucagon concentrations. Caloric restriction also improves hepatic steatosis and lowers fasting AA. These changes may represent restoration of glucagon's hepatic actions. This experiment will determine whether caloric restriction improves glucagon's actions on hepatic amino acid, carbohydrate and lipid metabolism in T2DM in comparison to a baseline experiment performed separately in people with T2DM.

Trial arms

Trial start

2022-12-15

Estimated PCD

2026-06-30

Trial end

2026-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Caloric Restriction

Subjects will be instructed to consume a diet of 900 kcal daily using meals derived from "Nutritional Guidelines after Bariatric Surgery". Compliance will be monitored by weekly meetings with the dietician using an electronic record of food intake

Arms:

Adults with type 2 diabetes

Hyperglycemic clamp

Hyperglycemic clamp to measure the effect of glucagon on hepatic metabolism

Arms:

Adults with type 2 diabetes

Size

Primary endpoint

Rate of leucine oxidation in response to rising glucagon concentrations

240 minutes of study

Eligibility criteria

Inclusion Criteria: * We will recruit up to 20 weight-stable, subjects with type 2 diabetes * BMI ≥ 28 Kg/M2 * Diabetes is managed by diet alone or a combination of oral agents Exclusion Criteria: * History of prior upper abdominal surgery e.g. gastric banding, pyloroplasty, vagotomy. * Active systemic illness or malignancy. * Symptomatic macrovascular or microvascular disease. * Contraindications to MRI (e.g. metal implants, claustrophobia). * Hematocrit \< 35% * TSH \< 0.4 or \> 5.5. * Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'caloric restriction for six weeks', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-05-29

1 organization

Organization

Adrian Vella