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

ConditionType2diabetes

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age25-65

SponsorAdrian Vella

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

Caloric Restriction
Behavioral
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
Hyperglycemic clamp
Drug
Hyperglycemic clamp to measure the effect of glucagon on hepatic metabolism

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Adults with type 2 diabetesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Rate of leucine oxidation in response to rising glucagon concentrations

tracer-determined amino acid catabolism

Time frame

240 minutes of study

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adrian Vella

Lead sponsor

Mayo Clinic

Sponsor institution

Source ClinicalTrials.gov

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